OncoMatch/Clinical Trials/NCT03715933
Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Is NCT03715933 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments for ewing sarcoma.
Treatment: INBRX-109 · Irinotecan · Temozolomide · carboplatin · pemetrexed · Leucovorin · Fluorouracil · Bevacizumab · Trifluridine + Tipiracil — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Sarcoma
Colorectal Cancer
Biomarker criteria
Required: EWSR1 classical fusion
Histologically confirmed Ewing sarcoma with a classical fusion
Demographics
Prior therapy
Must have received: systemic therapy — Ewing sarcoma
have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens
Must have received: systemic therapy — colorectal adenocarcinoma
Patients who have failed 1 (one) prior line of systemic therapy that did not include irinotecan
Must have received: systemic therapy — colorectal adenocarcinoma
Patients who have failed 2 but no more than 3 prior lines of systemic therapy and are FTD/TPI-naïve
Cannot have received: DR5 agonist
Prior treatment with or exposure to DR5 agonists
Cannot have received: allogeneic hematopoietic stem cell or bone marrow transplantation
Exception: Exceptions per protocol
Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.
Lab requirements
Blood counts
Adequate hematologic, coagulation function as defined per protocol
Kidney function
Adequate renal function as defined per protocol
Liver function
Adequate hepatic function as defined per protocol
Adequate hematologic, coagulation, hepatic and renal function as defined per protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- HonorHealth Research Institute · Scottsdale, Arizona
- Precision NextGen Oncology and Research · Beverly Hills, California
- City of Hope · Duarte, California
- Valkyrie Clinical Trials · Los Angeles, California
- University of California, San Diego (UCSD) - Moores Cancer Center · San Diego, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03715933 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior DR5 agonist, allogeneic hematopoietic stem cell or bone marrow transplantation disqualifies patients from enrollment.
Does this trial require EWSR1?
Yes, EWSR1 classical fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger and at least 12 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages