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

May 20, 2026 updated by: Inhibrx Biosciences, Inc

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

411

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon Berard
        • Principal Investigator:
          • Mehdi Brahmi, MD
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy
        • Principal Investigator:
          • Pablo Berlanga, MD
  • Italy
      • Candiolo, Italy, 10060
        • Recruiting
        • La Fondazione e l'Istituto di Candiolo
        • Principal Investigator:
          • Sandra Aliberti, MD
      • Milan, Italy, 20123
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori
        • Principal Investigator:
          • Roberto Luksch, MD
        • Principal Investigator:
          • Salvatore Provenzano, MD
  • Netherlands
      • Groningen, Netherlands
        • Recruiting
        • University Medical Center Groningen
        • Principal Investigator:
          • Jacco de Haan, MD
      • Leiden, Netherlands
        • Recruiting
        • Academisch Ziekenhuis Leiden
        • Principal Investigator:
          • André (Hans) Gelderblom, MD
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Principal Investigator:
          • Elena Elez, MD
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Ana Sebio Garcia, MD
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Principal Investigator:
          • Antonio Casado Herraez
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
        • Principal Investigator:
          • Andrea Napolitano, MD
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital
        • Principal Investigator:
          • Sandra Strauss, MD
      • London, United Kingdom, EC4V 3BJ
        • Recruiting
        • Great North Children's Hospital
        • Principal Investigator:
          • Quentin Campbell-Hewson, MD
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Royal Manchester Children's Hospital
        • Principal Investigator:
          • Bernadette Maria Dymphna Brennan
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Completed
        • HonorHealth Research Institute
    • California
      • Beverly Hills, California, United States, 90212
        • Recruiting
        • Precision NextGen Oncology and Research
        • Principal Investigator:
          • Kamalesh Sankhala, MD
        • Contact:
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Principal Investigator:
          • Marwan Fakih, MD
        • Contact:
      • Los Angeles, California, United States, 90067
      • San Diego, California, United States, 92093
        • Withdrawn
        • University of California, San Diego (UCSD) - Moores Cancer Center
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California, San Francisco (UCSF)
        • Principal Investigator:
          • Varun Monga, MD
        • Contact:
      • Santa Monica, California, United States, 90403
        • Recruiting
        • Sarcoma Oncology Center
        • Contact:
        • Principal Investigator:
          • Sant P Chawla, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Principal Investigator:
          • Christopher Lieu, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University - Winship Cancer Institute
        • Principal Investigator:
          • Olatunji Alese, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Completed
        • The University of Chicago
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Rashmi Chugh, MD
        • Contact:
      • Grand Rapids, Michigan, United States, 49546
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Emily Slotkin, MD
        • Contact:
          • Care Advisors
          • Phone Number: 833-675-5437
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael D Deel, MD
      • Cleveland, Ohio, United States, 44195
        • Completed
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Principal Investigator:
          • Michael Heinrich, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Recruiting
        • University of Pennsylvania Abramson Cancer Center
        • Contact:
        • Principal Investigator:
          • Lee Hartner, MD
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University School of Medicine
        • Principal Investigator:
          • Elizabeth Davis, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT MD Anderson Cancer Center
        • Principal Investigator:
          • David Hong, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Completed
        • Next Oncology
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Ludimila Cavalcante, MD
        • Contact:
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 who have failed 1 (one) prior line of systemic therapy that did not include irinotecan.
    • Colorectal adenocarcinoma: Patients who have failed 2 but no more than 3 prior lines of systemic therapy and are FTD/TPI-naïve.
  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.
  9. Chronic liver diseases including fatty liver. Exception: Patients < 45 years old with fatty liver disease may be accepted as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
  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.

  12. Known sensitivity or contraindications to the following drugs:

    • Ewing sarcoma: irinotecan or TMZ
    • colorectal adenocarcinoma: FU, leucovorin, irinotecan, bevacizumab or FTP/TPI
  13. Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.
  14. Acute, hemodynamically significant deep vein thrombosis or clinically significant pulmonary embolism not resolved or stable for at least 3 months prior to the start of study treatment.
  15. Major surgery within 4 weeks prior to enrollment on this trial.
  16. Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
  17. Other exclusion criteria per protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation (Complete)
INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Experimental: Expansion Malignant Pleural Mesothelioma (Complete)
Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Experimental: Expansion Gastric Adenocarcinoma (Complete)
Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Experimental: Expansion Colorectal Adenocarcinoma (Complete)
Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Experimental: Expansion Sarcomas (Complete)
Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Experimental: Combination Expansion Malignant Pleural Mesothelioma (Complete)
Subjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Drug: carboplatin
chemotherapy
Drug: pemetrexed
chemotherapy
Experimental: Combination Expansion Pancreatic Adenocarcinoma (Complete)
Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
Drug: Irinotecan
Chemotherapy
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Drug: Leucovorin
chemotherapy
Drug: Fluorouracil
chemotherapy
Experimental: Expansion Solid Tumors (Complete)
Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Experimental: Combination Expansion SDH-deficient solid tumors or GIST (Complete)
Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Drug: Temozolomide
Chemotherapy
Experimental: Combination Expansion Colorectal Adenocarcinoma (Complete)
Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
Drug: Irinotecan
Chemotherapy
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Drug: Leucovorin
chemotherapy
Drug: Fluorouracil
chemotherapy
Experimental: Combination Expansion Adult Ewing Sarcoma
Adult subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Drug: Irinotecan
Chemotherapy
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Drug: Temozolomide
Chemotherapy
Experimental: Combination Expansion Colorectal Adenocarcinoma patients with FOLFIRI plus bevacizumab
Colorectal adenocarcinoma will be treated with INBRX-109 with FOLFIRI (FU, leucovorin, and irinotecan) plus bevacizumab
Drug: Irinotecan
Chemotherapy
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Drug: Leucovorin
chemotherapy
Drug: Fluorouracil
chemotherapy
Drug: Bevacizumab
targeted therapy
Experimental: Combination Expansion Colorectal Adenocarcinoma with FTD/TPI plus bevacizumab
Colorectal adenocarcinoma will be treated with INBRX-109 with FTD/TPI plus bevacizumab
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Drug: Bevacizumab
targeted therapy
Drug: Trifluridine + Tipiracil
chemotherapy
Experimental: Combination Expansion Adolescent Ewing Sarcoma
Adolescent (12 to <18) subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Drug: Irinotecan
Chemotherapy
Drug: INBRX-109
Tetravalent DR5 Agonist Antibody
Drug: Temozolomide
Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and severity of adverse events of INBRX-109
Time Frame: Up to 8 years
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 8 years
Evaluating Tumor Response for colorectal cancers and Ewing sarcoma
Time Frame: Up to 8 years
Evaluating how the tumor responds to treatment by measuring the number of patients with colorectal cancer and Ewing sarcoma that experience tumor shrinkage and for how long.
Up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of INBRX-109
Time Frame: Up to 8 years
Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.
Up to 8 years
Characterize the pharmacokinetics of INBRX-109 as a single agent, and of INBRX-109 in combination with distinct chemotherapies.
Time Frame: Up to 8 years
A measurement which indicates how the body processes INBRX-109 and how long it stays in the system.
Up to 8 years
Median progression-free survival for colorectal adenocarcinoma and Ewing sarcoma.
Time Frame: Up to 8 years
Progression-free survival is defined as the time from start of study treatment until documented disease progression or death.
Up to 8 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-tumor activity of INBRX-109
Time Frame: Up to 8 years
Tumor response will be determined by RECISTv1.1.
Up to 8 years
Potential predictive response biomarkers
Time Frame: Up to 8 years
Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109
Up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inhibrx Biosciences, Inc

Investigators

  • Study Director: Clinical Lead, Inhibrx Biosciences, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2018

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ph1 INBRX-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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