RECRUITING

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

Conditions

Solid Tumors Malignant Pleural Mesothelioma Gastric Adenocarcinoma Colorectal Adenocarcinoma Sarcoma Pancreatic Adenocarcinoma Ewing Sarcoma Chondrosarcoma GIST SDH-deficient Solid Tumors Phase 1 Phase 1 Clinical Trial Pleural Mesothelioma Stomach Cancer Colorectal Cancer Colon Cancer Rectal Cancer DR5

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2018-10-10

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03715933

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Study Director, -Inhibrx

CONTACT

858-500-7833

clinicaltrials@inhibrx.com

Principal Investigator

Clinical Lead

STUDY_DIRECTOR

Inhibrx Biosciences, Inc

Study Locations (Sites)

HonorHealth Research Institute

Scottsdale, Arizona, 85258

United States

City of Hope

Duarte, California, 91010

United States

Valkyrie Clinical Trials

Los Angeles, California, 90067

United States

University of California, San Diego (UCSD) - Moores Cancer Center

San Diego, California, 92093

United States

Sarcoma Oncology Center

Santa Monica, California, 90403

United States

University of Colorado Hospital

Aurora, Colorado, 80045

United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322

United States

The University of Chicago

Chicago, Illinois, 60637

United States

Center for Cancer Research at NCI

Bethesda, Maryland, 20892

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

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

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19106

United States

Vanderbilt University School of Medicine

Nashville, Tennessee, 37232

United States

UT MD Anderson Cancer Center

Houston, Texas, 77030

United States

NEXT Oncology

San Antonio, Texas, 78229

United States

NEXT Oncology - Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Inhibrx Biosciences, Inc

Clinical Lead, STUDY_DIRECTOR, Inhibrx Biosciences, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-10

Study Completion Date2026-07

Study Record Updates

Study Start Date2018-10-10

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Solid Tumors
Malignant Pleural Mesothelioma
Gastric Adenocarcinoma
Colorectal Adenocarcinoma
Sarcoma
Pancreatic Adenocarcinoma
Ewing Sarcoma
Chondrosarcoma
GIST
SDH-deficient Solid Tumors