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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03715933
Other study ID # Ph1 INBRX-109
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 10, 2018
Est. completion date July 2026

Study information

Verified date April 2024
Source Inhibrx, Inc.
Contact Study Director, -Inhibrx
Phone 858-500-7833
Email clinicaltrials@inhibrx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date July 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 85 Years
Eligibility 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 Design


Intervention

Drug:
INBRX-109
Tetravalent DR5 Agonist Antibody
Carboplatin
Chemotherapy
Cisplatin
Chemotherapy
Pemetrexed
Chemotherapy
5-fluorouracil
Chemotherapy
Irinotecan
Chemotherapy
Temozolomide
Chemotherapy

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Emory University - Winship Cancer Institute Atlanta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Center for Cancer Research at NCI Bethesda Maryland
United States The University of Chicago Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States City of Hope Duarte California
United States NEXT Oncology - Virginia Fairfax Virginia
United States START Midwest Michigan, PC Grand Rapids Michigan
United States UT MD Anderson Cancer Center Houston Texas
United States Valkyrie Clinical Trials Los Angeles California
United States Vanderbilt University School of Medicine Nashville Tennessee
United States David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York New York
United States University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States NEXT Oncology San Antonio Texas
United States University of California, San Diego (UCSD) - Moores Cancer Center San Diego California
United States Sarcoma Oncology Center Santa Monica California
United States HonorHealth Research Institute Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Inhibrx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Anti-tumor activity of INBRX-109 Tumor response will be determined by RECISTv1.1. Up to 2 years
Primary 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. Up to 2 years
Primary 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. Up to 2 years
Secondary 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. Up to 2 years
Secondary Immunogenicity of INBRX-109 Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined. Up to 2 years
Secondary Maximum observed serum concentration (Cmax) of INBRX-109 Maximum observed serum concentration (Cmax) of INBRX-109 will be determined. Up to 2 years
Secondary Trough observed serum concentration (Ctrough) of INBRX-109 Trough observed serum concentration (Cmax) of INBRX-109 will be determined. Up to 2 years
Secondary Time to Cmax (Tmax) of INBRX-109 Time to Cmax (Tmax) of INBRX-109 will be determined. Up to 2 years
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