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New antibody drug takes aim at Hard-to-Treat cancers

NCT ID NCT03715933

Disease control Sponsor: Inhibrx Biosciences, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called INBRX-109 in people with advanced solid tumors, including Ewing sarcoma and colorectal cancer. The drug is designed to attach to a protein on cancer cells and trigger their death. The main goals are to check safety and see if the drug can shrink tumors. About 411 participants will take part in this study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 411 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma Ewing sarcoma sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal adenocarcinoma Ewing sarcoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Academisch Ziekenhuis Leiden

    RECRUITING

    Leiden, Netherlands

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Children's Hospital of Orange County-Rady Children's Health

    RECRUITING

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia- Center for Childhood Cancer Research

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    COMPLETED

    Cleveland, Ohio, 44195, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Emory University - Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20123, Italy

  • Great North Children's Hospital

    RECRUITING

    London, EC4V 3BJ, United Kingdom

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • HonorHealth Research Institute

    COMPLETED

    Scottsdale, Arizona, 85258, United States

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • La Fondazione e l'Istituto di Candiolo

    RECRUITING

    Candiolo, 10060, Italy

  • NEXT Oncology

    COMPLETED

    San Antonio, Texas, 78229, United States

  • NEXT Oncology - Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Precision NextGen Oncology and Research

    RECRUITING

    Beverly Hills, California, 90212, United States

  • Royal Manchester Children's Hospital

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • START Midwest Michigan, PC

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Sarcoma Oncology Center

    RECRUITING

    Santa Monica, California, 90403, United States

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The University of Chicago

    COMPLETED

    Chicago, Illinois, 60637, United States

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University College London Hospital

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Medical Center Groningen

    RECRUITING

    Groningen, Netherlands

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

    WITHDRAWN

    San Diego, California, 92093, United States

  • University of California, San Francisco (UCSF)

    RECRUITING

    San Francisco, California, 94110, United States

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19106, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Vanderbilt University School of Medicine

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.