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Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT03715933•Inhibrx Biosciences, Inc

View on ClinicalTrials.gov

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).

Eligibility

Age

12 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.
•2. Part 3 combination therapy expansion tumor types:
•* Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.
•* Colorectal adenocarcinoma: Patients with locally advanced or metastatic, unresectable disease, who have received at least 2 but no more than 3 prior lines of systemic therapy.
•3. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
•4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
•5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, or Karnofsky Performance Status score of ≥60, or Lansky Play-Performance Scale for Children score ≥60 (for patients less than 16 years).
•6. Estimated life expectancy of at least 12 weeks.
•7. Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion Criteria

•1. Prior treatment with or exposure to DR5 agonists.
•2. 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.
•3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
•4. 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.
•5. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.
•6. Prior or concurrent malignancies. Exceptions per protocol.
•7. Hematologic malignancies.
•8. Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol. Patients with any evidence or history of multiple sclerosis (MS) or other demyelinating disorders are excluded.
•10. Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.
•11. Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
+7 more criteria

Locations (35)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Precision NextGen Oncology and Research

Beverly Hills, California, United States

City of Hope

Duarte, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

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

San Diego, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

The University of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

October 8, 2018

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

March 18, 2026

Enrollment

321

ESTIMATED participants

Conditions

Ewing Sarcoma

Interventions

INBRX-109

DRUG

Irinotecan

DRUG

Temozolomide

DRUG

carboplatin

DRUG

pemetrexed

DRUG

Leucovorin

DRUG

Fluorouracil

DRUG

Contacts

Study Director, -Inhibrx

CONTACT

858-500-7833 clinicaltrials@inhibrx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

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Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas