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

NCT03715933 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2026-05-22

No results posted yet for this study

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).

Conditions

  • Ewing Sarcoma
  • Colorectal Adenocarcinoma

Interventions

DRUG

INBRX-109

Tetravalent DR5 Agonist Antibody

DRUG

Irinotecan

Chemotherapy

DRUG

Temozolomide

Chemotherapy

DRUG

carboplatin

chemotherapy

DRUG

pemetrexed

chemotherapy

DRUG

Leucovorin

chemotherapy

DRUG

Fluorouracil

chemotherapy

DRUG

Bevacizumab

targeted therapy

DRUG

Trifluridine + Tipiracil

chemotherapy

Sponsors & Collaborators

  • Inhibrx Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Clinical Lead · Inhibrx Biosciences, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2028-12-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715933 on ClinicalTrials.gov