CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 411 target
Drug / intervention
INBRX-109 +8 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Ewing sarcoma patients aged 12 to <85 years
  • ✓Colorectal adenocarcinoma patients aged 18 to <85 years
  • ✓Ewing sarcoma: locally advanced or metastatic, unresectable, relapsed, or refractory disease
  • ✓Ewing sarcoma with classical fusion confirmed histologically
Key exclusion· 16
  • ✕Prior treatment with DR5 agonists
  • ✕Allergy or sensitivity to INBRX-109 or CHO-produced antibodies
  • ✕Symptomatic active primary CNS tumors or CNS metastases
  • ✕Evidence or history of multiple sclerosis or demyelinating disorders

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03715933
NCT03715933Phase 1RecruitingHigh Momentum
Long Recruiting
CompareCT.gov

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

Inhibrx Biosciences, Inc·interventional·Posted Oct 23, 2018·Updated May 22, 2026

In Brief

A Phase 1 clinical trial evaluating INBRX-109, Irinotecan, and 7 other interventions for Ewing Sarcoma and Colorectal Adenocarcinoma. Currently recruiting, targeting 411 participants across 36 sites in 6 countries.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEwing Sarcoma, Colorectal Adenocarcinoma
CountriesFrance, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 1Recruiting
20192020202120222023202420252026202720282029
First PostedOct 23, 2018
Enrollment StartOct 8, 2018
Primary CompletionDec 1, 2028
Study CompletionJun 1, 2029
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 7.7 years agoPrimary completion in 2.4 years

Interventions

INBRX-109drug

Tetravalent DR5 Agonist Antibody

Irinotecandrug

Chemotherapy

Temozolomidedrug

Chemotherapy

carboplatindrug

chemotherapy

pemetrexeddrug

chemotherapy

Leucovorindrug

chemotherapy

Fluorouracildrug

chemotherapy

Bevacizumabdrug

targeted therapy

Trifluridine + Tipiracildrug

chemotherapy