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A Study of ACR-368 in Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma

Primary Purpose

Platinum-resistant Ovarian Cancer, Endometrial Adenocarcinoma, Urothelial Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ACR-368
Gemcitabine
OncoSignature
Sponsored by
Acrivon Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platinum-resistant Ovarian Cancer focused on measuring Urothelial Carcinoma, Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasm, Urogenital Neoplasm, Endometrial Cancer, Endometrial Neoplasm, Ovarian Cancer, Ovarian Neoplasm, Ultralow dose gemcitabine, Platinum-resistant Ovarian Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criterial: General

  1. Participants who are 18 years of age or older at time of consent.
  2. Participant must be able to give signed, written informed consent.
  3. Participant must have histologically confirmed, locally advanced (ie, not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
  4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria (by local Investigator) (Eisenhauer, 2009). Participant must have radiographic evidence of disease progression based on RECIST criteria following the most recent line of treatment. Biochemical recurrence (eg, CA-125 in ovarian carcinoma) only is not considered as disease progression.
  5. Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated. Newly obtained is defined as a specimen obtained up to 12 weeks prior to initiation of treatment on Day 1 if no intercurrent systemic therapy in the interval. For biopsies obtained prior to the signing of the consent, Investigators should contact the Medical Monitor to confirm sample will be acceptable.
  6. Participant must be willing to provide an archival tumor tissue block or at least 20 unstained slides, if available.
  7. Participant must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxicities, except as follows: Alopecia is accepted. Endocrine events from prior immunotherapy stabilized at ≤ Grade 2 due to need for replacement therapy are accepted (including hypothyroidism, diabetes mellitus, or adrenal insufficiency). Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted.
  8. Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1.
  9. Participant must have an estimated life expectancy of longer than 3 months.
  10. Participant must have adequate organ function at Screening, defined as: Absolute neutrophil count > 1500 cells/µL without growth factor support within 1 week prior to obtaining the hematology values at Screening. Hemoglobin ≥ 9.0 g/dL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at Screening. Platelets ≥ 100,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening. Calculated creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft Gault formula. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present. Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable. Serum albumin ≥ 3 g/dL.
  11. Participant must have adequate coagulation profile as defined below (including if receiving anticoagulation therapy): Prothrombin time within the ULN. Activated partial thromboplastin time within the ULN. If the patient is anticoagulated, must be on a stable dose of anticoagulant for ≥ 1 month.

Tumor Specific Inclusion Criteria

For Ovarian Carcinoma:

  1. Participant must have histologically documented, platinum resistant, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy, is eligible. Primary platinum refractory disease, defined as progression while on the upfront platinum-based therapy, is not eligible.
  2. Participant must have received at least 1 but no more than 6 prior lines of systemic therapy, including at least 1 line of therapy containing platinum derivative and taxane, and single-agent therapy must be appropriate as the next line of treatment:
  3. Participant must have had prior bevacizumab or did not receive bevacizumab based on Investigator judgment (see Section 2.1.1).

For Endometrial Carcinoma

  1. Participant must have histologically documented, high-grade endometrial adenocarcinoma.

    1. All Grade 3 International Federation of Gynecology and Obstetrics epithelial endometrial histologies are eligible including: endometrioid, serous, and clear-cell carcinoma.
    2. Carcinosarcoma is eligible. Enrollment of participants with this histology will be capped at 5% for each cohort.
    3. Participant must have no more than 3 prior lines of therapy in the recurrent setting, including platinum-based chemotherapy for subtypes of endometrial adenocarcinoma where it is a standard of care.
  2. Participant must have documented failure or ineligibility (based on Investigator judgement) for prior anti-programmed cell death protein 1/anti-programmed death-ligand 1 (PD 1/PD L1) immunotherapy as single agent or in combination with lenvatinib for advanced/metastatic disease. Prior combination of PD 1/PD L1 inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor is acceptable.

For Urothelial Carcinoma

  1. Participant must have histologically documented, advanced (metastatic and/or unresectable) urothelial carcinoma. Variant histology is allowed as long as the tumor is predominantly urothelial.
  2. Participants must have:

    1. Received a platinum containing regimen (cisplatin or carboplatin) in the metastatic/locally advanced, neoadjuvant, or adjuvant setting. If platinum was administered in the adjuvant/neoadjuvant setting, participant must have progressed within 12 months of completion.
    2. Failed or have been ineligible for checkpoint inhibitors (including PD-1 or PD-L1 inhibitors).
    3. Failed or have been ineligible for enfortumab vedotin.
    4. Have no known life-prolonging therapy available

Exclusion Criteria: General

  1. Participant with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment.
  2. Participant had a failure to recover from the reversible effects of prior anti-cancer therapy, as follows:

    a. Endocrine events from prior immunotherapy at Grade > 2. b. Neuropathy events from prior cytotoxic therapies at Grade > 2. c. All other reversible effects of prior anti-cancer therapy (except alopecia) at Grade >1 or Baseline.

  3. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
  4. Participants has known human immunodeficiency virus, hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in Appendix 2.
  5. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis.
  6. Participant has cardiovascular disease, defined as:

    1. Uncontrolled hypertension defined as blood pressure > 160/90 mmHg at Screening confirmed by repeat (medication permitted).
    2. History of torsades de pointes, significant Screening electrocardiogram (ECG) abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree atrioventricular (AV) block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT (QTc) > 450 msec (for men) or > 470 msec (for women).
    3. Symptomatic heart failure (per New York Heart Association guidelines; (Caraballo, 2019), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction < 20%, transient ischemic attack, or cerebrovascular accident within 6 months of Day 1).
  7. Participant has a history of major surgery within 4 weeks of Screening.
  8. Participant has a history of bowel obstruction requiring decompression through a nasogastric tube within 8 weeks of Screening. Participants has signs or symptoms of intestinal obstruction, which include nausea, vomiting, and objective radiologic finding of bowel obstruction.
  9. Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368

Tumor Specific Exclusion Criteria

For Ovarian Carcinoma:

  1. Participant has non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma.
  2. Participant has a history of clinically meaningful ascites, defined as a history of paracentesis or thoracentesis within 4 weeks of Screening.
  3. Participant has a history of active inflammatory bowel disease within 2 years prior to Screening.
  4. Participant has a history of bowel perforation, fistula, necrosis, or leak within 8 weeks of Screening.

For Endometrial Adenocarcinoma:

  1. Participant has low-grade endometrioid carcinoma.
  2. Participant has mesenchymal tumors of the uterus.
  3. Participant has a history of clinically meaningful ascites, defined as a history of paracentesis or thoracentesis within 4 weeks of Screening.

For Urothelial Carcinoma:

  1. Participant has sarcoma, carcinosarcoma, melanoma, or lymphoma of the bladder.
  2. Participant has not received a previous platinum-based regimen.
  3. Participant has small cell or neuroendocrine histology.

Sites / Locations

  • University of South Alabama Mitchell Cancer InstituteRecruiting
  • Alaska Women's Cancer CenterRecruiting
  • HonorHealthRecruiting
  • Arizona Oncology Associate, PC- HOPERecruiting
  • University of Arkansas for Medical SciencesRecruiting
  • City of Hope National Medical CenterRecruiting
  • UC San Diego Moores Cancer CenterRecruiting
  • USC/Norris Comprehensive Cancer CenterRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • Hoag Cancer CenterRecruiting
  • UC Irvine HealthRecruiting
  • University of California Los Angeles (UCLA)Recruiting
  • University of ColoradoRecruiting
  • Yale Cancer CenterRecruiting
  • Florida Gynecologic Oncology/Regional Cancer CenterRecruiting
  • Mount Sinai Comprehensive Cancer CenterRecruiting
  • Emory UniversityRecruiting
  • Northeast Georgia Medical CenterRecruiting
  • Northwestern MedicineRecruiting
  • University of Illinois Cancer CenterRecruiting
  • Carle Cancer CenterRecruiting
  • LSU Health SciencesRecruiting
  • Trials365, LLCRecruiting
  • American Oncology Partners of Maryland PARecruiting
  • National Institutes of Health, Clinical CenterRecruiting
  • Holy Cross HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • University of Massachusetts Chan Medical SchoolRecruiting
  • Karmanos Cancer InstituteRecruiting
  • HCA MidwestRecruiting
  • John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
  • Rutgers Cancer Institute of NJRecruiting
  • Laura & Isaac Perlmutter Cancer CenterRecruiting
  • Memorial Sloan-Kettering Cancer CenterRecruiting
  • FirstHealth of the CarolinasRecruiting
  • Gabrail Cancer CenterRecruiting
  • Miami Valley Hospital SouthRecruiting
  • University of Cincinnati Cancer CenterRecruiting
  • Cleveland Clinic FoundationRecruiting
  • Stephenson Cancer Center at OU HealthRecruiting
  • Oncology Associates of OregonRecruiting
  • Fox Chase Cancer CenterRecruiting
  • West Penn HospitalRecruiting
  • Women & Infants HospitalRecruiting
  • Sanford HealthRecruiting
  • Texas Oncology-Dallas Presbyterian HospitalRecruiting
  • Texas OncologyRecruiting
  • University of Texas, MD Anderson Cancer CenterRecruiting
  • Huntsman Cancer Institute, University of UtahRecruiting
  • University of Virginia Health SystemRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • Swedish Cancer CenterRecruiting
  • Fred Hutchinson Cancer CenterRecruiting
  • Providence Sacred Heart Medical Center and Children's HospitalRecruiting
  • Summit Cancer CenterRecruiting
  • Northwest Cancer Specialists, P.C.Recruiting
  • Froedtert and Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

OncoSignature Positive Tumors

OncoSignature Negative or Unevaluable test

Arm Description

In Arm 1, participants with an OncoSignature Positive test will enter a Phase 2 Simon 2-Stage Study that will assess the efficacy of ACR-368 as monotherapy in each of the 3 cohorts of participants (ovarian, endometrial, and urothelial).

In Arm 2, participants with an OncoSignature Negative will receive the combination of ACR-368 and ultralow Dose Gemcitabine (ULDG). The Phase 1b/2 portion will only enroll participants with OncoSignature Negative tumors. Unevaluable tumors will not be able to participate. A Phase 1b Study will assess the safety of the combination of ACR-368 and escalating doses of ULDG in participants with any of the 3 tumor types (ovarian, endometrial, and urothelial). The Phase 1b Study will determine the recommended Phase 2 dose (RP2D) of ULDG. When determined, a Phase 2 Exploratory Study will be initiated to assess the efficacy and safety of the combination of ACR-368 and the RP2D of ULDG in each of the 3 cohorts of participants (ovarian, endometrial, and urothelial).

Outcomes

Primary Outcome Measures

Arm 1 Monotherapy: Anti-tumor activity of ACR-368 in Ovarian, Endometrial, and Urothelial Cohorts
Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging for the number of participants with a partial or complete response.
Arm 2 Phase 1b: Adverse Events (AEs) for ACR-368 in combination with ULDG
Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
Arm 2 Phase 1b: Determine the RP2D of ULDG
The RP2D will be evaluated by the incidence of DLT events per dose level
Arm 2 Exploratory Phase 2: Anti-tumor activity of ACR-368 plus ULDG in Ovarian, Endometrial and Urothelial Cohorts
Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging for the number of participants with a partial or complete response.

Secondary Outcome Measures

Arm 1: Number of subjects with confirmed OncoSignature thresholds for enrichment of ACR-368 monotherapy responders
Response data including tumor shrinkage at first imaging and progression by computed tomography or magnetic resonance imaging for the first 12 participants in each tumor type
Arm 1: Adverse Events (AEs) for ACR-368 monotherapy
Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
Relative dose intensity of ACR-368
Assess the ratio of cumulative administered dose to the planned dose for first 2 cycles
Arm 1: Limited pharmacokinetic (PK) testing in participants with Ovarian Carcinoma
Cmax will be assessed in the first cycle at baseline, end of infusion, hour 2 and hour 4
Arm 2: Limited pharmacokinetic (PK) testing of ACR-368 in combination with ULDG in all participants in Phase 1b
Cmax will be assessed in the first cycle at baseline, end of infusion, hour 2 and hour 4
Overall Survival (OS)
The time from baseline until date of death
Duration of Response (DOR)
The time from initial response until investigator assessed progressive disease for all subjects who achieve a confirmed objective response.
Progression-free Survival (PFS)
The time from baseline until second disease progression or death whichever occurs first.

Full Information

First Posted
August 29, 2022
Last Updated
October 23, 2023
Sponsor
Acrivon Therapeutics
Collaborators
GOG Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05548296
Brief Title
A Study of ACR-368 in Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma
Official Title
A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination With Gemcitabine in Adult Subjects With Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acrivon Therapeutics
Collaborators
GOG Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or in combination with ultralow dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.
Detailed Description
Participants will be selected for predicted efficacy of ACR-368 using the OncoSignature® Companion Diagnostic test. Participants will be allocated to one of 2 arms based on OncoSignature result: Arm 1: OncoSignature Positive tumors Arm 2: OncoSignature Negative Participants in Arm 1 will receive ACR-368 as monotherapy. Participants in Arm 2 will receive the combination of ACR-368 and ultralow-dose gemcitabine. Participants in both arms will be treated until disease progression, unacceptable toxicity or any criterion for stopping the study drug or withdrawal from the trial occurs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum-resistant Ovarian Cancer, Endometrial Adenocarcinoma, Urothelial Carcinoma
Keywords
Urothelial Carcinoma, Bladder Cancer, Urinary Bladder Neoplasm, Urologic Neoplasm, Urogenital Neoplasm, Endometrial Cancer, Endometrial Neoplasm, Ovarian Cancer, Ovarian Neoplasm, Ultralow dose gemcitabine, Platinum-resistant Ovarian Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants with an OncoSignature positive test will enter a Phase 2 study that will assess the efficacy of ACR-368 as monotherapy in each of the 3 tumor types, ovarian, endometrial, and urothelial carcinomas. Participants with an OncoSignature negative test will be entered in a Phase 1b study to assess the safety of the combination of ACR-368 and escalating doses of ultralow dose gemcitabine (ULDG) in each of the 3 tumor types. When the recommended Phase 2 (RP2D) dose is determined, participants will be entered in an exploratory Phase 2 study to assess the efficacy and safety of ACR-368 and the RP2D of ULDG in each of the 3 tumor types.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OncoSignature Positive Tumors
Arm Type
Experimental
Arm Description
In Arm 1, participants with an OncoSignature Positive test will enter a Phase 2 Simon 2-Stage Study that will assess the efficacy of ACR-368 as monotherapy in each of the 3 cohorts of participants (ovarian, endometrial, and urothelial).
Arm Title
OncoSignature Negative or Unevaluable test
Arm Type
Experimental
Arm Description
In Arm 2, participants with an OncoSignature Negative will receive the combination of ACR-368 and ultralow Dose Gemcitabine (ULDG). The Phase 1b/2 portion will only enroll participants with OncoSignature Negative tumors. Unevaluable tumors will not be able to participate. A Phase 1b Study will assess the safety of the combination of ACR-368 and escalating doses of ULDG in participants with any of the 3 tumor types (ovarian, endometrial, and urothelial). The Phase 1b Study will determine the recommended Phase 2 dose (RP2D) of ULDG. When determined, a Phase 2 Exploratory Study will be initiated to assess the efficacy and safety of the combination of ACR-368 and the RP2D of ULDG in each of the 3 cohorts of participants (ovarian, endometrial, and urothelial).
Intervention Type
Drug
Intervention Name(s)
ACR-368
Other Intervention Name(s)
prexasertib
Intervention Description
ACR-368 is an experimental drug
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine is a standard of care given at ultralow dose in combination with the experimental drug ACR-368
Intervention Type
Diagnostic Test
Intervention Name(s)
OncoSignature
Intervention Description
Biomarker profile based on prediction of drug sensitivity performed on biopsy tissue
Primary Outcome Measure Information:
Title
Arm 1 Monotherapy: Anti-tumor activity of ACR-368 in Ovarian, Endometrial, and Urothelial Cohorts
Description
Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging for the number of participants with a partial or complete response.
Time Frame
Response will be assessed every 8 weeks from baseline through 2 years or death.
Title
Arm 2 Phase 1b: Adverse Events (AEs) for ACR-368 in combination with ULDG
Description
Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
Time Frame
AEs will be assessed from baseline through 2 years or death.
Title
Arm 2 Phase 1b: Determine the RP2D of ULDG
Description
The RP2D will be evaluated by the incidence of DLT events per dose level
Time Frame
AEs will be assessed from first dose of ULDG for 28 days for each subject in a cohort.
Title
Arm 2 Exploratory Phase 2: Anti-tumor activity of ACR-368 plus ULDG in Ovarian, Endometrial and Urothelial Cohorts
Description
Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging for the number of participants with a partial or complete response.
Time Frame
Response will be assessed every 8 weeks from baseline through 2 years or death.
Secondary Outcome Measure Information:
Title
Arm 1: Number of subjects with confirmed OncoSignature thresholds for enrichment of ACR-368 monotherapy responders
Description
Response data including tumor shrinkage at first imaging and progression by computed tomography or magnetic resonance imaging for the first 12 participants in each tumor type
Time Frame
Baseline to first post treatment imaging at 8 weeks
Title
Arm 1: Adverse Events (AEs) for ACR-368 monotherapy
Description
Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
Time Frame
AEs will be assessed from baseline through 2 years or death.
Title
Relative dose intensity of ACR-368
Description
Assess the ratio of cumulative administered dose to the planned dose for first 2 cycles
Time Frame
First dose of ACR-368 in first cycle to dose on day 15 of second cycle of administration
Title
Arm 1: Limited pharmacokinetic (PK) testing in participants with Ovarian Carcinoma
Description
Cmax will be assessed in the first cycle at baseline, end of infusion, hour 2 and hour 4
Time Frame
Dose of ACR-368 at day 1 and day 15 of first cycle
Title
Arm 2: Limited pharmacokinetic (PK) testing of ACR-368 in combination with ULDG in all participants in Phase 1b
Description
Cmax will be assessed in the first cycle at baseline, end of infusion, hour 2 and hour 4
Time Frame
Dose of ACR-368 at day 1 and day 15 of first cycle
Title
Overall Survival (OS)
Description
The time from baseline until date of death
Time Frame
Up to 2 years
Title
Duration of Response (DOR)
Description
The time from initial response until investigator assessed progressive disease for all subjects who achieve a confirmed objective response.
Time Frame
Up to 2 years
Title
Progression-free Survival (PFS)
Description
The time from baseline until second disease progression or death whichever occurs first.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criterial: General Participant must be able to give signed, written informed consent. Participant must have histologically confirmed, locally advanced (i.e., not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria (by local Investigator) (Eisenhauer, 2009). Participant must have radiographic evidence of disease progression based on RECIST criteria following the most recent line of treatment. Biochemical recurrence (eg, CA-125 in ovarian carcinoma) only is not considered as disease progression. Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after signed informed consent. Newly obtained is defined as a specimen obtained up to 6 weeks prior to initiation of treatment on Day 1 if no intercurrent systemic therapy in the interval. Participant must be willing to provide an archival tumor tissue block or at least 20 unstained slides, if available. Participant must have stabilized or recovered (Grade 1 or baseline) from all prior therapy related toxicities, except as follows: Alopecia is accepted. Endocrine events from prior immunotherapy stabilized at ≤ Grade 2 due to need for replacement therapy are accepted (including hypothyroidism, diabetes mellitus, or adrenal insufficiency). Neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2 are accepted. Participant must have an Eastern Cooperative Oncology Group Performance Status 0 or 1. Participant must have an estimated life expectancy of longer than 3 months. Participant must have adequate organ function at Screening, defined as: Absolute neutrophil count > 1500 cells/µL without growth factor support within 1 week prior to obtaining the hematology values at Screening. Hemoglobin ≥ 9.0 g/dL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at Screening. Platelets ≥ 100,000 cells/µL without transfusion within 1 week prior to obtaining the hematology values at Screening. Calculated creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft Gault formula. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); ≤ 5 × ULN if liver metastases are present. Total bilirubin ≤ 1.5 × ULN not associated with Gilbert's syndrome. If associated with Gilbert's syndrome ≤ 3 x ULN is acceptable. Serum albumin ≥ 3 g/dL. Participant must have adequate coagulation profile as defined below (including if receiving anticoagulation therapy): Prothrombin time within 1.5 x ULN. Activated partial thromboplastin time within 1.5 x ULN. If the patient is anticoagulated, must be on a stable dose of anticoagulant for ≥ 1 month. Tumor Specific Inclusion Criteria For Ovarian Carcinoma: Participant must have histologically documented, platinum resistant, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy, is eligible. Platinum sensitive disease, defined as disease which progress after 6 or more months after the completion of platinum-based therapy and primary platinum refractory disease, defined as progression while on the upfront platinum-based therapy, is not eligible. a. Carcinosarcoma is eligible. Participant must have received at least 1 but no more than 6 prior lines of systemic therapy, including at least 1 line of therapy containing platinum derivative and taxane, and single-agent therapy must be appropriate as the next line of treatment: Participant must have had prior bevacizumab or did not receive bevacizumab based on Investigator judgment (see Section 2.1.1). For Endometrial Carcinoma Participant must have histologically documented, high-grade endometrial adenocarcinoma. All Grade 3 International Federation of Gynecology and Obstetrics epithelial endometrial histologies are eligible including: endometrioid, serous, and clear-cell carcinoma. Carcinosarcoma is eligible. Enrollment of participants with this histology will be capped at 5% for each cohort. Participant must have no more than 3 prior lines of therapy in the recurrent setting, including platinum-based chemotherapy for subtypes of endometrial adenocarcinoma where it is a standard of care. Participant must have documented failure or ineligibility (based on Investigator judgement) for prior anti-programmed cell death protein 1/anti-programmed death- ligand 1 (PD 1/PD L1) based therapy for advanced/metastatic disease. Prior combination of PD 1/PD L1 inhibitor and vascular endothelial growth factor tyrosine kinase inhibitor is acceptable. For Urothelial Carcinoma Participant must have histologically documented, advanced (metastatic and/or unresectable) urothelial carcinoma. Variant histology is allowed as long as the tumor is predominantly urothelial. Participants must have: Received a platinum containing regimen (cisplatin or carboplatin) in the metastatic/locally advanced, neoadjuvant, or adjuvant setting. If platinum was administered in the adjuvant/neoadjuvant setting, participant must have progressed within 12 months of completion. Failed or have been ineligible for checkpoint inhibitors (including PD-1 or PD-L1 inhibitors). Failed or have been ineligible for enfortumab vedotin. Have no known life-prolonging therapy available Exclusion Criteria: General Participant with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment. Participant had a failure to recover from the reversible effects of prior anti-cancer therapy, as follows: Endocrine events from prior immunotherapy at Grade > 2. Neuropathy events from prior cytotoxic therapies at Grade > 2. All other reversible effects of prior anti- cancer therapy (except alopecia) at Grade >1 or Baseline. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug. Participants has known human immunodeficiency virus, hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in Appendix 2. Participant has a history of clinically meaningful coagulopathy, bleeding diathesis. Participant has cardiovascular disease, defined as: Uncontrolled hypertension defined as blood pressure > 160/90 mmHg at Screening confirmed by repeat (medication permitted). History of torsades de pointes, significant Screening electrocardiogram (ECG) abnormalities, including ventricular rhythm disturbances, unstable cardiac arrhythmia requiring medication, pathologic symptomatic bradycardia, left bundle branch block, second degree atrioventricular (AV) block type II, third degree AV block, Grade ≥ 2 bradycardia, uncorrected hypokalemia not amenable to correction, congenital long QT syndrome, prolonged QT interval due to medications, corrected QT (QTc) > 450 msec (for men) or > 470 msec (for women). Symptomatic heart failure (per New York Heart Association guidelines; (Caraballo, 2019), unstable angina, myocardial infarction, severe cardiovascular disease (ejection fraction < 20%, transient ischemic attack, or cerebrovascular accident within 6 months of Day 1). Participant has a history of major surgery within 4 weeks of Screening. Participant has a history of bowel obstruction requiring decompression through a nasogastric tube within 8 weeks of Screening. Participants has signs or symptoms of intestinal obstruction, which include nausea, vomiting, and objective radiologic finding of bowel obstruction. Participant has taken a prior cell cycle CHK1 inhibitor, including ACR-368 Tumor Specific Exclusion Criteria For Ovarian Carcinoma: Participant has non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma. Participant has a history of clinically meaningful ascites, defined as a history of paracentesis or thoracentesis within 4 weeks of Screening. Participant has a planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing. Participant has a history of active inflammatory bowel disease within 2 years prior to Screening. Participant has a history of bowel perforation, fistula, necrosis, or leak within 8 weeks of Screening. For Endometrial Adenocarcinoma: Participant has low-grade endometrioid carcinoma. Participant has mesenchymal tumors of the uterus. Participant has a history of clinically meaningful ascites, defined as a history of paracentesis or thoracentesis within 4 weeks of Screening. Participant has a planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing. For Urothelial Carcinoma: Participant has sarcoma, carcinosarcoma, melanoma, or lymphoma of the bladder. Participant has not received a previous platinum-based regimen. Participant has small cell or neuroendocrine histology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erick Gamelin, MD
Phone
617-207-8976
Email
ACR-368-201ClinicalTrial@acrivon.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanie Tang
Email
ACR-368-201ClinicalTrial@acrivon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Min Lee, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Rosenberg, MD
Organizational Affiliation
Memorial Sloan-Kettering Cancer Center (MSKCC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefanie White
First Name & Middle Initial & Last Name & Degree
Jennifer Scalici, MD
Facility Name
Alaska Women's Cancer Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katelyn Kammers
First Name & Middle Initial & Last Name & Degree
Melissa Hardesty, MD, MPH
Facility Name
HonorHealth
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Thomas
First Name & Middle Initial & Last Name & Degree
Bradley Monk, MD
Facility Name
Arizona Oncology Associate, PC- HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Kimball
First Name & Middle Initial & Last Name & Degree
Joseph Buscema, MD
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maroof Zafar
First Name & Middle Initial & Last Name & Degree
Heather Williams, MD
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorna Rodriguez, MD
First Name & Middle Initial & Last Name & Degree
Mihae Song, MD
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeline Kirkegaard
First Name & Middle Initial & Last Name & Degree
Alexandrea Cronin
First Name & Middle Initial & Last Name & Degree
Ramez Eskander, MD
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Areieli
First Name & Middle Initial & Last Name & Degree
Koji Matsuo, MD
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Arman
First Name & Middle Initial & Last Name & Degree
Garrett Crook
First Name & Middle Initial & Last Name & Degree
Bobbie Rimel, MD
Facility Name
Hoag Cancer Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esmerelda Martinez
First Name & Middle Initial & Last Name & Degree
Alberto Mendivil, MD
Facility Name
UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothy Huttar
First Name & Middle Initial & Last Name & Degree
Nataliya Mar, MD
Facility Name
University of California Los Angeles (UCLA)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Vazquez
First Name & Middle Initial & Last Name & Degree
Alexandra Drakaki, MD
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler Poon
First Name & Middle Initial & Last Name & Degree
Lindsay Brubaker, MD
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Palma
First Name & Middle Initial & Last Name & Degree
Joseph W. Kim, MD
Facility Name
Florida Gynecologic Oncology/Regional Cancer Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samith Sandadi
First Name & Middle Initial & Last Name & Degree
Edward Grendys, MD
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Lacombe
First Name & Middle Initial & Last Name & Degree
Brian Slomovitz, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilena Session
First Name & Middle Initial & Last Name & Degree
Mehmet Bilen, MD
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trena Davis
First Name & Middle Initial & Last Name & Degree
Andrew E. Green, MD
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Burrows
First Name & Middle Initial & Last Name & Degree
Daniela Matei, MD
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercedes Carrasquillo
First Name & Middle Initial & Last Name & Degree
Shannon MacLaughlan, MD
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendrith Rowland
First Name & Middle Initial & Last Name & Degree
Pratima Chalasani, MD
Facility Name
LSU Health Sciences
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krystal Giddix
First Name & Middle Initial & Last Name & Degree
Amelia Jernigan, MD
Facility Name
Trials365, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Kay
First Name & Middle Initial & Last Name & Degree
Destin Black, MD
Facility Name
American Oncology Partners of Maryland PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Bongiorno
First Name & Middle Initial & Last Name & Degree
Mark Goldstein, MD
Facility Name
National Institutes of Health, Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann McCoy, RN
First Name & Middle Initial & Last Name & Degree
Jung-Min Lee, MD
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujana Lalagari
First Name & Middle Initial & Last Name & Degree
James F Barter, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hope Needham
First Name & Middle Initial & Last Name & Degree
Panagiotis Konstantinopoulos, MD, PhD
Facility Name
University of Massachusetts Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Pepka-Jones
First Name & Middle Initial & Last Name & Degree
Cara Gregoire
First Name & Middle Initial & Last Name & Degree
Susan Zweizig, MD
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Morris, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ira Winer, MD, PhD
Facility Name
HCA Midwest
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Werner
First Name & Middle Initial & Last Name & Degree
Kristopher LyBarger, DO
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Wiest
First Name & Middle Initial & Last Name & Degree
Donna McNamara, MD
Facility Name
Rutgers Cancer Institute of NJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Jackson
First Name & Middle Initial & Last Name & Degree
Aliza Leiser, MD
Facility Name
Laura & Isaac Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Estok
First Name & Middle Initial & Last Name & Degree
Bhavana Pothuri, MD
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrisann Kyi, MD
First Name & Middle Initial & Last Name & Degree
Jonathan Rosenberg, MD
Facility Name
FirstHealth of the Carolinas
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Mason
First Name & Middle Initial & Last Name & Degree
Michael J. Sundborg, MD
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Roby
First Name & Middle Initial & Last Name & Degree
Nashat Gabrail, MD
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Wirth
First Name & Middle Initial & Last Name & Degree
Michael Guy, MD
Facility Name
University of Cincinnati Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margan Harris
First Name & Middle Initial & Last Name & Degree
Caroline Billingsley, MD
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Gilligan
First Name & Middle Initial & Last Name & Degree
Moshe Ornstein
First Name & Middle Initial & Last Name & Degree
Shilpa Gupta, MD
Facility Name
Stephenson Cancer Center at OU Health
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
phase1-referrals@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Debra Richardson, MD
Facility Name
Oncology Associates of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Schaffer
First Name & Middle Initial & Last Name & Degree
Charles Anderson, MD
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Katona
First Name & Middle Initial & Last Name & Degree
Angela Jain, MD
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siobhan Guyach
First Name & Middle Initial & Last Name & Degree
Sarah Crafton, MD
Facility Name
Women & Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
oncologyresearch@wihri.org
First Name & Middle Initial & Last Name & Degree
Cara Mathews, MD
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Johnson
First Name & Middle Initial & Last Name & Degree
Maria Bell, MD
Facility Name
Texas Oncology-Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Jones
First Name & Middle Initial & Last Name & Degree
Kristi J. McIntyre, MD
Facility Name
Texas Oncology
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynora Sullivan
First Name & Middle Initial & Last Name & Degree
Noelle Cloven, MD
Facility Name
University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Eckert
First Name & Middle Initial & Last Name & Degree
Funda Meric-Bernstam, MD
Facility Name
Huntsman Cancer Institute, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine Saenz
First Name & Middle Initial & Last Name & Degree
Theresa Werner, MD
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jungeun Kim
First Name & Middle Initial & Last Name & Degree
Linda Duska, MD
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Hamilton
First Name & Middle Initial & Last Name & Degree
Leslie Randall, MD
Facility Name
Swedish Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Nguyen
First Name & Middle Initial & Last Name & Degree
Fernanda Musa, MD
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Panlasigui
First Name & Middle Initial & Last Name & Degree
Petros Grivas, MD, PhD
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodie Mactagone
First Name & Middle Initial & Last Name & Degree
Melanie Bergman, MD
Facility Name
Summit Cancer Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Chaudhry
First Name & Middle Initial & Last Name & Degree
Arvind Chaudhry, MD, PhD
Facility Name
Northwest Cancer Specialists, P.C.
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Lassiter
First Name & Middle Initial & Last Name & Degree
Weiya Wysham, MD
Facility Name
Froedtert and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subarna Paul
First Name & Middle Initial & Last Name & Degree
William Bradley, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://acrivon.com
Description
Related Info

Learn more about this trial

A Study of ACR-368 in Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma

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