Colon Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Males or females aged ≥12 to <85 years for Ewing sarcoma and 18 to <85 years of age for GIST.
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 any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.
Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.
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.
Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol.
Chronic liver disease including but not limited to cirrhosis, non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), alcohol-related liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, multiple liver hemangioma (except incidental finding of clinically nonsignificant liver hemangioma), hepatic or biliary autoimmune disorders (ie, primary biliary cholangitis, autoimmune hepatitis), history of portal or hepatic vein thrombosis, and sinusoidal occlusion syndrome. Exceptions per protocol.
Acute viral or toxic liver disease within 12 months 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;
Sensitivity or contraindications to INBRX-109, irinotecan, or temozolomide.
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.
Pregnant or nursing females.
Patients who are receiving strong cytochrome P450 (CYP) 3A inhibitors and/or inducers, and/or UGT1A1 inhibitors within 14 days of Cycle 1 Day 1.

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

240

Study ID:

NCT03715933

Recruitment Status:

Recruiting

Sponsor:

Inhibrx, Inc.

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There are 19 Locations for this study

See Locations Near You

HonorHealth Research Institute
Scottsdale Arizona, 85258, United States
City of Hope
Duarte California, 91010, United States More Info
Anahita Nersiseyan Malhami
Contact
818-726-2563
[email protected]
New Patient Services Coordinator
Contact
1-800-826-4673
[email protected]
Mark Agulnik, MD
Principal Investigator
Valkyrie Clinical Trials
Los Angeles California, 90067, United States More Info
Leila Mirtagui
Contact
[email protected]
David Berz, MD
Principal Investigator
University of California, San Diego (UCSD) - Moores Cancer Center
San Diego California, 92093, United States More Info
Adam Burgoyne, MD
Principal Investigator
Sarcoma Oncology Center
Santa Monica California, 90403, United States More Info
Victoria Chua-Alcala
Contact
310-552-9999
[email protected]
Sant P Chawla, MD
Principal Investigator
University of Colorado Hospital
Aurora Colorado, 80045, United States More Info
Trace Dimos
Contact
[email protected]
Christopher Lieu, MD
Principal Investigator
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States More Info
Suzanne Scott
Contact
404-778-4083
Olatunji Alese, MD
Principal Investigator
The University of Chicago
Chicago Illinois, 60637, United States
Center for Cancer Research at NCI
Bethesda Maryland, 20892, United States More Info
J Glod
Contact
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Myron Hepner
Contact
[email protected]
Rashmi Chugh, MD
Principal Investigator
START Midwest Michigan, PC
Grand Rapids Michigan, 49546, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States More Info
Care Advisors
Contact
833-675-5437
Emily Slotkin, MD
Principal Investigator
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Jessica Grebenc
Contact
[email protected]
Dale Shepard, MD
Principal Investigator
Oregon Health & Science University
Portland Oregon, 97239, United States More Info
Sarah Tressel
Contact
503-494-0824
[email protected]
Michael Heinrich, MD
Principal Investigator
University of Pennsylvania Abramson Cancer Center
Philadelphia Pennsylvania, 19106, United States More Info
Sarcoma Research
Contact
[email protected]
Lee Hartner, MD
Principal Investigator
Vanderbilt University School of Medicine
Nashville Tennessee, 37232, United States More Info
Elizabeth Davis, MD
Principal Investigator
UT MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jihyun Shin
Contact
713-792-6934
[email protected]
David Hong, MD
Principal Investigator
NEXT Oncology
San Antonio Texas, 78229, United States
NEXT Oncology - Virginia
Fairfax Virginia, 22031, United States More Info
Kayla Grossi
Contact
[email protected];
Alexander Spira, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

240

Study ID:

NCT03715933

Recruitment Status:

Recruiting

Sponsor:


Inhibrx, Inc.

How clear is this clinincal trial information?

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