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64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT) (COMBAT)

Primary Purpose

Prostatic Neoplasms, Castration-Resistant

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
64Cu-SAR-BBN
67Cu-SAR-BBN
Sponsored by
Clarity Pharmaceuticals Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

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

Inclusion Criteria: Signed informed consent; ≥18 years of age; Eastern Cooperative Oncology Group performance status of 0 to 2; Life expectancy >6 months; Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa); ≥1 Metastatic lesion that is present at screening computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained <28 days prior to enrollment into the study; Positive 64Cu-SAR-BBN positron emission tomography (PET)/CT scan, where 64Cu-SAR-BBN uptake (standardized uptake value [SUV] max) of at least 1 known lesion is positive (higher than that of the liver) and all lesions on anatomical imaging larger in short axis than size criteria are also positive [size criteria: organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component ≥ 1 cm] on the 1 hour PET/CT scan; Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L); Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy (ADT) and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria: Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL; Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions; Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan. Participants must be ineligible for 177Lu-PSMA-617 therapy based on the following criterion:Uptake of 68Ga-PSMA-11 or 18F-DCFPyL in all lesions is negative (equal to or lower than that of liver parenchyma), or any one lesion larger than the size criteria is negative [size criteria: organs ≥1 cm, lymph nodes ≥2.5 cm, bones(soft tissue component) ≥1 cm]. Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.); Participants must have adequate organ function: Bone marrow reserve: White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1.5 x 109 /L is equivalent to 1.5 x 103 /μL and 1.5 x K/μL and 1.5 x 103 /cc and 1500/μL); Platelets ≥100 x 109 /L (100 x 109 /L is equivalent to 100 x 103 /μL and 100 x K/μL and 100 x 103 /cc and 100,000/μL); Hemoglobin ≥9 g/dL (5.59 mmol/L); Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted; Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases; Estimated glomerular filtration rate (eGFR) ≥50 mL/min For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator; For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection. Exclusion Criteria: Major surgery within 12 weeks prior to enrollment into the study; Symptomatic Brain metastasis; Histologic diagnosis of small cell prostate cancer; Prior history of leukemia or Myelodysplastic Syndrome; Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study; Unmanageable urinary tract obstruction; Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is Gastrin-releasing peptide receptor (GRPR) negative on the 1 hour 64Cu-SAR-BBN PET/CT scan as determined at screening; Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor; Previous treatment with any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is discontinued prior to enrolment, 14 days must elapse after abiraterone discontinuation and 28 days after enzalutamide before participant can be enrolled) or low dose corticosteroids; Previous treatment with any investigational agents within 4 weeks prior enrollment into the study; Known hypersensitivity to the components of the investigational products or its analogues; Transfusion for the sole purpose of making a participant eligible for study inclusion; Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression; Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation; Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer; Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g. uncontrolled urinary incontinence, high dependency care); Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study; Participants with corrected QT interval (QTc) > 470 msec; Participants with persistent acute and/or chronic pancreatitis.

Sites / Locations

  • Stanford University
  • Biogenix MolecularRecruiting
  • BAMF Health, IncRecruiting
  • XCancer Omaha LLCRecruiting
  • Duke University
  • M D Anderson Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

67Cu-SAR-BBN

Arm Description

In the dose escalation phase: 64Cu-SAR-BBN: Patients will receive up to 2 administrations of 200MBq 67Cu-SAR-BBN: Cohorts 1 - 3: Single administration (dose will be determined based on cohort allocation). Cohort 4: 2 administrations at the recommended dose (determined by cohorts 1-3). In the cohort expansion phase: Patients will receive up to 3 administrations of 200MBq of 64Cu-SAR-BBN and 2 administrations at the recommended dose level of 67Cu-SAR-BBN, determined through the dose escalation. Additional administrations: (up to a maximum total of 4) may be offered to those participants, in either the dose escalation or cohort expansion, with radiological non-progression.

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of a single dose of 67Cu-SAR-BBN
MTD as determined by cohort observations of dose limiting toxicities or MFD determined by the activity of the dose to be administered, when the MTD has not been reached.
Recommended dose of two doses of 67Cu-SAR-BBN
Recommended dose as determined by cohort observations of dose limiting toxicities
Efficacy of 67Cu-SAR-BBN in terms of Prostate Specific Antigen (PSA) response
Proportion of participants with ≥50% decline in PSA
Efficacy of 67Cu-SAR-BBN in terms of radiographic response
Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according to PCWG3 for bone lesions
Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN
Incidence of dose limiting toxicities following a single administration of 67Cu-SAR-BBN
Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN
Incidence of dose limiting toxicities following repeated administrations of 67Cu-SAR-BBN
Incidence of 67Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5, following single or repeated administrations of 67Cu-SAR-BBN
Incidence of 67Cu-SAR-BBN adverse event of special interest [Safety and tolerability]
Protocol defined adverse event of special interest following single or repeated administrations of 67Cu-SAR-BBN
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in vital signs
Change from baseline in vital signs following single or repeated administrations of 67Cu-SAR-BBN
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in electrocardiogram (ECG) parameters
Change from baseline in ECG parameters following single or repeated administrations 67Cu-SAR-BBN
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in laboratory results
Change from baseline in laboratory results following single or repeated administrations 67Cu-SAR-BBN
Incidence of 64Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5, following single or repeated administrations of 64Cu-SAR-BBN

Secondary Outcome Measures

Full Information

First Posted
November 21, 2022
Last Updated
September 25, 2023
Sponsor
Clarity Pharmaceuticals Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05633160
Brief Title
64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT)
Acronym
COMBAT
Official Title
A Phase I/IIa Theranostic Study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for Identification and Treatment of GRPR-expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarity Pharmaceuticals Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic castrate resistant prostate cancer in patients who are ineligible for therapy with 177Lu-PSMA-617.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Castration-Resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
67Cu-SAR-BBN
Arm Type
Experimental
Arm Description
In the dose escalation phase: 64Cu-SAR-BBN: Patients will receive up to 2 administrations of 200MBq 67Cu-SAR-BBN: Cohorts 1 - 3: Single administration (dose will be determined based on cohort allocation). Cohort 4: 2 administrations at the recommended dose (determined by cohorts 1-3). In the cohort expansion phase: Patients will receive up to 3 administrations of 200MBq of 64Cu-SAR-BBN and 2 administrations at the recommended dose level of 67Cu-SAR-BBN, determined through the dose escalation. Additional administrations: (up to a maximum total of 4) may be offered to those participants, in either the dose escalation or cohort expansion, with radiological non-progression.
Intervention Type
Drug
Intervention Name(s)
64Cu-SAR-BBN
Intervention Description
64Cu-SAR-BBN
Intervention Type
Drug
Intervention Name(s)
67Cu-SAR-BBN
Intervention Description
67Cu-SAR-BBN
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) or maximum feasible dose (MFD) of a single dose of 67Cu-SAR-BBN
Description
MTD as determined by cohort observations of dose limiting toxicities or MFD determined by the activity of the dose to be administered, when the MTD has not been reached.
Time Frame
Up to 8 weeks
Title
Recommended dose of two doses of 67Cu-SAR-BBN
Description
Recommended dose as determined by cohort observations of dose limiting toxicities
Time Frame
Up to 14 weeks
Title
Efficacy of 67Cu-SAR-BBN in terms of Prostate Specific Antigen (PSA) response
Description
Proportion of participants with ≥50% decline in PSA
Time Frame
Up to 5 years
Title
Efficacy of 67Cu-SAR-BBN in terms of radiographic response
Description
Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according to PCWG3 for bone lesions
Time Frame
Up to 5 years
Title
Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN
Description
Incidence of dose limiting toxicities following a single administration of 67Cu-SAR-BBN
Time Frame
Up to 8 weeks
Title
Incidence of dose limiting toxicities [Safety and tolerability] of 67Cu-SAR-BBN
Description
Incidence of dose limiting toxicities following repeated administrations of 67Cu-SAR-BBN
Time Frame
Up to 14 weeks
Title
Incidence of 67Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
Description
Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5, following single or repeated administrations of 67Cu-SAR-BBN
Time Frame
Up to 12 months
Title
Incidence of 67Cu-SAR-BBN adverse event of special interest [Safety and tolerability]
Description
Protocol defined adverse event of special interest following single or repeated administrations of 67Cu-SAR-BBN
Time Frame
Up to 5 years
Title
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in vital signs
Description
Change from baseline in vital signs following single or repeated administrations of 67Cu-SAR-BBN
Time Frame
Up to 24 weeks
Title
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in electrocardiogram (ECG) parameters
Description
Change from baseline in ECG parameters following single or repeated administrations 67Cu-SAR-BBN
Time Frame
Up to 24 weeks
Title
Safety and tolerability of 67Cu-SAR-BBN: Number of Participants with changes from baseline in laboratory results
Description
Change from baseline in laboratory results following single or repeated administrations 67Cu-SAR-BBN
Time Frame
Up to 52 weeks
Title
Incidence of 64Cu-SAR-BBN treatment-emergent adverse events [Safety and tolerability]
Description
Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5, following single or repeated administrations of 64Cu-SAR-BBN
Time Frame
Up to 12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent; ≥18 years of age; Eastern Cooperative Oncology Group performance status of 0 to 2; Life expectancy >6 months; Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa); ≥1 Metastatic lesion that is present at screening computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained <28 days prior to enrollment into the study; Positive 64Cu-SAR-BBN positron emission tomography (PET)/CT scan, where 64Cu-SAR-BBN uptake (standardized uptake value [SUV] max) of at least 1 known lesion is positive (higher than that of the liver) and all lesions on anatomical imaging larger in short axis than size criteria are also positive [size criteria: organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component ≥ 1 cm] on the 1 hour PET/CT scan; Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L); Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy (ADT) and at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors). Documented progressive mCRPC will be based on at least 1 of the following criteria: Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal value for study enrollment is 2.0 ng/mL; Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since the last treatment directed at the metastatic cancer has started (not including hormonal therapy) or the appearance of 1 or more new lesions; Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan. Participants must be ineligible for 177Lu-PSMA-617 therapy based on the following criterion:Uptake of 68Ga-PSMA-11 or 18F-DCFPyL in all lesions is negative (equal to or lower than that of liver parenchyma), or any one lesion larger than the size criteria is negative [size criteria: organs ≥1 cm, lymph nodes ≥2.5 cm, bones(soft tissue component) ≥1 cm]. Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy, etc.); Participants must have adequate organ function: Bone marrow reserve: White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR Absolute neutrophil count (ANC) ≥1.5 x 109 /L (1.5 x 109 /L is equivalent to 1.5 x 103 /μL and 1.5 x K/μL and 1.5 x 103 /cc and 1500/μL); Platelets ≥100 x 109 /L (100 x 109 /L is equivalent to 100 x 103 /μL and 100 x K/μL and 100 x 103 /cc and 100,000/μL); Hemoglobin ≥9 g/dL (5.59 mmol/L); Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted; Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for participants with liver metastases; Estimated glomerular filtration rate (eGFR) ≥50 mL/min For participants who are human immunodeficiency virus infected: Participant must be healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes in the opinion of the Investigator; For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection. Exclusion Criteria: Major surgery within 12 weeks prior to enrollment into the study; Symptomatic Brain metastasis; Histologic diagnosis of small cell prostate cancer; Prior history of leukemia or Myelodysplastic Syndrome; Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to enrollment into the study; Unmanageable urinary tract obstruction; Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation Criteria in Solid Tumors V1.1) that is Gastrin-releasing peptide receptor (GRPR) negative on the 1 hour 64Cu-SAR-BBN PET/CT scan as determined at screening; Previous treatment with a systemic radionuclide, including 177Lu, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131 within 6 months or in case of Radium-223 within 3 months of treatment initiation (Day 0) without prior approval of the medical monitor; Previous treatment with any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 4 weeks prior to treatment on study with the exception of Luteinizing Hormone Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is discontinued prior to enrolment, 14 days must elapse after abiraterone discontinuation and 28 days after enzalutamide before participant can be enrolled) or low dose corticosteroids; Previous treatment with any investigational agents within 4 weeks prior enrollment into the study; Known hypersensitivity to the components of the investigational products or its analogues; Transfusion for the sole purpose of making a participant eligible for study inclusion; Spinal metastasis with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression; Concurrent serious medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation; Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer; Any condition or personal situation that would pose an unacceptable radiation safety risk (as per institution guidelines, state and/or national regulations) to the participant or carer at the time of release following the completion of therapy (e.g. uncontrolled urinary incontinence, high dependency care); Participants in whom it is known that external beam radiation therapy is scheduled after enrollment into the study; Participants with corrected QT interval (QTc) > 470 msec; Participants with persistent acute and/or chronic pancreatitis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarity Pharmaceuticals
Phone
+61 (0) 2 9209 4037
Email
clinicaltrials@claritypharmaceuticals.com
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Dominguez
Phone
650-725-1070
Email
secure-prostate_radresearch-bounces@lists.stanford.edu
First Name & Middle Initial & Last Name & Degree
Hong Song, MD
Facility Name
Biogenix Molecular
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Alvarez
Phone
786-691-1799
Email
recruitment@biogenixmolecular.com
First Name & Middle Initial & Last Name & Degree
Frankis Almaguel, MD
Facility Name
BAMF Health, Inc
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton McNamara
Phone
888-870-8998
Email
researchclinicalteam@bamfhealth.com
First Name & Middle Initial & Last Name & Degree
Brandon Mancini, MD
Facility Name
XCancer Omaha LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Romero
Phone
402-991-8468
Email
tromero@gucancer.com
First Name & Middle Initial & Last Name & Degree
Laura Frank
Phone
402-991-8468
Email
lfrank@gucancer.com
First Name & Middle Initial & Last Name & Degree
Luke Nordquist, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Hurrelbrink
Phone
919-681-7460
Email
julia.hurrelbrink@duke.edu
First Name & Middle Initial & Last Name & Degree
Tasha Womack
Phone
919-668-0832
Email
tasha.womack@duke.edu
First Name & Middle Initial & Last Name & Degree
Andrew Armstrong, MD
Facility Name
M D Anderson Cancer Centre
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynda Nelson
Phone
713-792-2830
Email
guclinicaltrials@mdanderson.org

12. IPD Sharing Statement

Learn more about this trial

64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT)

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