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Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Primary Purpose

Solid Tumors, Malignant Pleural Mesothelioma, Gastric Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INBRX-109
Carboplatin
Cisplatin
Pemetrexed
5-fluorouracil
Irinotecan
Temozolomide
Sponsored by
Inhibrx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumors focused on measuring Phase 1, Phase 1 Clinical Trial, Solid Tumors, Sarcoma, Pleural Mesothelioma, Stomach Cancer, Colorectal Cancer, Colon Cancer, Rectal Cancer, DR5, Gastric Adenocarcinoma, Colorectal Adenocarcinoma, Pancreatic Adenocarcinoma, Ewing Sarcoma, Chondrosarcoma

Eligibility Criteria

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

Inclusion Criteria:

  • Escalation: Histologically or cytologically-confirmed advanced/metastatic or non-resectable solid tumors, including sarcoma, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
  • Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma and certain sarcoma subtypes (e.g., chondrosarcoma, Ewing sarcoma), GIST, and SDH-def solid tumors with locally advanced or metastatic, non-resectable disease, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit.
  • Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
  • Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 for Part 1 and ECOG PS of 0, 1 or 2 for Parts 2 and 3.

Exclusion Criteria:

  • Prior treatment with or exposure to DR5 agonists.
  • Receipt of investigational agents or devices, anticancer therapy and radiotherapy (with the exception of palliative localized radiation) within 4 weeks prior to the first dose of study drug, and liver-directed therapies (i.e., RFA, TACE/embolization, cryotherapy, SBRT) within 12 weeks prior to the first dose of study drug. Exceptions per protocol.
  • Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exception: Participants who have had a stem cell or bone marrow transplant > 5 years ago are eligible for enrollment, as long as there are no symptoms of graft-versus-host disease (GVHD).
  • Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-109.
  • Hematologic malignancies.
  • Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply.
  • Subjects with chronic liver diseases including but not limited to cirrhosis, NASH, alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatic or biliary autoimmune disorders (i.e., primary biliary cholangitis, autoimmune hepatitis).
  • Acute viral or toxic liver disease within 4 weeks prior to the first dose of study drug.
  • Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension. Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial.
  • Major surgery within 4 weeks prior to enrollment on this trial.
  • Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
  • Part 3: Sensitivity or contraindications to carboplatin, cisplatin, pemetrexed, fluorouracil, irinotecan, or temozolomide.

Sites / Locations

  • HonorHealth Research InstituteRecruiting
  • City of HopeRecruiting
  • Valkyrie Clinical TrialsRecruiting
  • University of California, San Diego (UCSD) - Moores Cancer Center
  • Sarcoma Oncology CenterRecruiting
  • University of Colorado HospitalRecruiting
  • Emory University - Winship Cancer InstituteRecruiting
  • The University of ChicagoRecruiting
  • University of MichiganRecruiting
  • START Midwest Michigan, PCRecruiting
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
  • Cleveland ClinicRecruiting
  • Oregon Health & Science UniversityRecruiting
  • University of Pennsylvania Abramson Cancer CenterRecruiting
  • Vanderbilt University School of Medicine
  • UT MD Anderson Cancer CenterRecruiting
  • NEXT Oncology
  • NEXT Oncology - VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation

Expansion Malignant Pleural Mesothelioma

Expansion Gastric Adenocarcinoma

Expansion Colorectal Adenocarcinoma

Expansion Sarcomas

Combination Expansion Malignant Pleural Mesothelioma

Combination Expansion Pancreatic Adenocarcinoma

Combination Expansion Ewing Sarcoma

Combination Expansion Colorectal Adenocarcinoma

Expansion Solid Tumors

Combination Expansion SDH-deficient solid tumors or GIST

Arm Description

INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.

Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)

Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy

Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide

Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy

Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.

Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide

Outcomes

Primary Outcome Measures

Frequency and severity of adverse events of INBRX-109
Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109
The MTD and/or RP2D of INBRX-109 will be determined.

Secondary Outcome Measures

Area under the serum concentration time curve (AUC) of INBRX-109
Area under the serum concentration time curve (AUC) of INBRX-109 will be determined.
Immunogenicity of INBRX-109
Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.
Maximum observed serum concentration (Cmax) of INBRX-109
Maximum observed serum concentration (Cmax) of INBRX-109 will be determined.
Trough observed serum concentration (Ctrough) of INBRX-109
Trough observed serum concentration (Cmax) of INBRX-109 will be determined.
Time to Cmax (Tmax) of INBRX-109
Time to Cmax (Tmax) of INBRX-109 will be determined.

Full Information

First Posted
October 11, 2018
Last Updated
August 4, 2023
Sponsor
Inhibrx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03715933
Brief Title
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Official Title
An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inhibrx, Inc.

4. Oversight

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

5. Study Description

Brief Summary
This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Malignant Pleural Mesothelioma, Gastric Adenocarcinoma, Colorectal Adenocarcinoma, Sarcoma, Pancreatic Adenocarcinoma, Ewing Sarcoma, Chondrosarcoma
Keywords
Phase 1, Phase 1 Clinical Trial, Solid Tumors, Sarcoma, Pleural Mesothelioma, Stomach Cancer, Colorectal Cancer, Colon Cancer, Rectal Cancer, DR5, Gastric Adenocarcinoma, Colorectal Adenocarcinoma, Pancreatic Adenocarcinoma, Ewing Sarcoma, Chondrosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
Arm Title
Expansion Malignant Pleural Mesothelioma
Arm Type
Experimental
Arm Description
Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Arm Title
Expansion Gastric Adenocarcinoma
Arm Type
Experimental
Arm Description
Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Arm Title
Expansion Colorectal Adenocarcinoma
Arm Type
Experimental
Arm Description
Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Arm Title
Expansion Sarcomas
Arm Type
Experimental
Arm Description
Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Arm Title
Combination Expansion Malignant Pleural Mesothelioma
Arm Type
Experimental
Arm Description
Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
Arm Title
Combination Expansion Pancreatic Adenocarcinoma
Arm Type
Experimental
Arm Description
Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
Arm Title
Combination Expansion Ewing Sarcoma
Arm Type
Experimental
Arm Description
Subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Arm Title
Combination Expansion Colorectal Adenocarcinoma
Arm Type
Experimental
Arm Description
Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
Arm Title
Expansion Solid Tumors
Arm Type
Experimental
Arm Description
Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Arm Title
Combination Expansion SDH-deficient solid tumors or GIST
Arm Type
Experimental
Arm Description
Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
Intervention Type
Drug
Intervention Name(s)
INBRX-109
Intervention Description
Tetravalent DR5 Agonist Antibody
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Frequency and severity of adverse events of INBRX-109
Description
Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time Frame
Up to 2 years
Title
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109
Description
The MTD and/or RP2D of INBRX-109 will be determined.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Area under the serum concentration time curve (AUC) of INBRX-109
Description
Area under the serum concentration time curve (AUC) of INBRX-109 will be determined.
Time Frame
Up to 2 years
Title
Immunogenicity of INBRX-109
Description
Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.
Time Frame
Up to 2 years
Title
Maximum observed serum concentration (Cmax) of INBRX-109
Description
Maximum observed serum concentration (Cmax) of INBRX-109 will be determined.
Time Frame
Up to 2 years
Title
Trough observed serum concentration (Ctrough) of INBRX-109
Description
Trough observed serum concentration (Cmax) of INBRX-109 will be determined.
Time Frame
Up to 2 years
Title
Time to Cmax (Tmax) of INBRX-109
Description
Time to Cmax (Tmax) of INBRX-109 will be determined.
Time Frame
Up to 2 years
Other Pre-specified Outcome Measures:
Title
Anti-tumor activity of INBRX-109
Description
Tumor response will be determined by RECISTv1.1.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Escalation: Histologically or cytologically-confirmed advanced/metastatic or non-resectable solid tumors, including sarcoma, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit. Expansion Cohorts: Malignant pleural mesothelioma, gastric adenocarcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma and certain sarcoma subtypes (e.g., chondrosarcoma, Ewing sarcoma), GIST, and SDH-def solid tumors with locally advanced or metastatic, non-resectable disease, that are refractory or intolerant to standard therapy, or for which no standard therapy exists that is likely to confer any clinical benefit. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 for Part 1 and ECOG PS of 0, 1 or 2 for Parts 2 and 3. Exclusion Criteria: Prior treatment with or exposure to DR5 agonists. Receipt of investigational agents or devices, anticancer therapy and radiotherapy (with the exception of palliative localized radiation) within 4 weeks prior to the first dose of study drug, and liver-directed therapies (i.e., RFA, TACE/embolization, cryotherapy, SBRT) within 12 weeks prior to the first dose of study drug. Exceptions per protocol. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exception: Participants who have had a stem cell or bone marrow transplant > 5 years ago are eligible for enrollment, as long as there are no symptoms of graft-versus-host disease (GVHD). Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-109. Hematologic malignancies. Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply. Subjects with chronic liver diseases including but not limited to cirrhosis, NASH, alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, hepatic or biliary autoimmune disorders (i.e., primary biliary cholangitis, autoimmune hepatitis). Acute viral or toxic liver disease within 4 weeks prior to the first dose of study drug. Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension. Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial. Major surgery within 4 weeks prior to enrollment on this trial. Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug. Part 3: Sensitivity or contraindications to carboplatin, cisplatin, pemetrexed, fluorouracil, irinotecan, or temozolomide.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miranda Fox, Trial Manager
Phone
858-500-7833
Email
clinicaltrials@inhibrx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Bayer, Clinical Director
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasily Andrianov, MD
Organizational Affiliation
Inhibrx, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Stainsz, RN
Email
nstanisz@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Sunil Sharma, MD
Facility Name
City of Hope
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
Anahita Nersiseyan Malhami
Phone
818-726-2563
Email
anersiseyan@coh.org
First Name & Middle Initial & Last Name & Degree
New Patient Services Coordinator
Phone
1-800-826-4673
Email
newpatientref@coh.org
First Name & Middle Initial & Last Name & Degree
Mark Agulnik, MD
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leila Mirtagui
Email
leila.mirtagui@valkyrieclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
David Berz, MD
Facility Name
University of California, San Diego (UCSD) - Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Burgoyne, MD
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Chua-Alcala
Phone
310-552-9999
Email
vchua@sarcomaoncology.com
First Name & Middle Initial & Last Name & Degree
Sant P Chawla, MD
Facility Name
University of Colorado Hospital
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
Trace Dimos
Email
trace.dimos@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Christopher Lieu, MD
Facility Name
Emory University - Winship Cancer Institute
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
Suzanne Scott
Phone
404-778-4083
First Name & Middle Initial & Last Name & Degree
Olatunji Alese, MD
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bianca Hill
Phone
773-834-1472
Email
bhill22@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Buerkley Rose
Phone
773-834-4002
Email
brose@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Hedy Kindler, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myron Hepner
Email
mhepner@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Rashmi Chugh, MD
Facility Name
START Midwest Michigan, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Burns
Phone
616-954-5559
Email
julie.burns@startmidwest.com
First Name & Middle Initial & Last Name & Degree
Nehal Lakhani, MD
Facility Name
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Larisa
Phone
646-888-4339
Email
larisac@mskcc.org
First Name & Middle Initial & Last Name & Degree
Ciara Kelly, MD
Facility Name
Cleveland Clinic
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
Heather Kearney
Phone
216-444-3409
Email
keaneyh@ccf.org
First Name & Middle Initial & Last Name & Degree
Dale Shepard, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Tressel
Phone
503-494-0824
Email
tressel@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Michael Heinrich, MD
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarcoma Research
Email
SarcomaResearch@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Lee Hartner, MD
Facility Name
Vanderbilt University School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Davis, MD
Facility Name
UT 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
Jihyun Shin
Phone
713-792-6934
Email
jishin@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Anna Lui
Phone
713-792-4843
Email
ALui@mdanderson.org
First Name & Middle Initial & Last Name & Degree
David Hong, MD
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NEXT Oncology - Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla Grossi
Email
kgrossi@nextoncology.com;
Email
NXTVIR_Coordinators@nextoncology.com
First Name & Middle Initial & Last Name & Degree
Alexander Spira, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

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