AzTrials
AzTrials

Ewing SarcomaPhase 1NCT03715933

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

A Phase 1 study testing INBRX-109, Irinotecan and Temozolomide in people with Ewing Sarcoma and Colorectal Adenocarcinoma, run by Inhibrx Biosciences, Inc at 37 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 12 to 85 years
Conditions the study is for
Ewing Sarcoma, Colorectal Adenocarcinoma
What is being tested?
INBRX-109, Irinotecan and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
411 participants
Where
37 sitesin 6 countries
Study dates
8 Oct 2018to Jun 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
Show all 10Show fewer
  • Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  • 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).
  • Estimated life expectancy of at least 12 weeks.
  • Availability of archival tissue or fresh cancer biopsy are mandatory.

Who cannot join

  • Prior treatment with or exposure to DR5 agonists.
  • 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.
  • Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
  • 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.
  • Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.
  • Prior or concurrent malignancies. Exceptions per protocol.
Show all 19Show fewer
  • Hematologic malignancies.
  • 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.
  • 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.
  • Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.
  • Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Known sensitivity or contraindications to the following drugs:
  • Ewing sarcoma: irinotecan or TMZ
  • colorectal adenocarcinoma: FU, leucovorin, irinotecan, bevacizumab or FTP/TPI
  • Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.
  • 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.
  • Major surgery within 4 weeks prior to enrollment on this trial.
  • Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
  • Other exclusion criteria per protocol.

Trial locations and contacts

37 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Study Director, -Inhibrx contact

858-500-7833

clinicaltrials@inhibrx.com

37 sites in 6 countries

United States24 sites, 19 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Myron Hepner, mhepner@med.umich.edu

    Rashmi Chugh, MD

    Recruiting

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

    Kimberly Homere, 404-778-6583, kimberly.homere@emory.edu

    Olatunji Alese, MD

    Recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Michaela Riley, michaela.riley@cuanschutz.edu

    Christopher Lieu, MD

    Recruiting

  • Precision NextGen Oncology and Research

    Beverly Hills, California, 90212

    Rebecca Godin, MSN, FNP, 424-777-0708, rebeccag@nextgenonc.com

    Ravleen Kaur, BS, (424) 777-0708, RavKaur@nextgenonc.com

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Sarah Sommer, 434-924-7613, ss2vz@uvahealth.org

    Ludimila Cavalcante, MD

    Recruiting

  • The University of Chicago

    Chicago, Illinois, 60637

    Completed

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Michael D Deel, MD, 513-636-3200, michael.deel@cchmc.org

    Lori Backus, BA, 513-636-2047, Lori.backus@cchmc.org

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Completed

  • City of Hope

    Duarte, California, 91010

    Heather Lewis, 626-256-4673, healewis@coh.org

    New Patient Services Coordinator, 1-800-826-4673, newpatientref@coh.org

    Recruiting

  • NEXT Oncology - Virginia

    Fairfax, Virginia, 22031

    Anthony Young, 703-783-4536, ayoung@nextoncology.com

    NXTVIR_Coordinators@nextoncology.com

    Recruiting

  • START Midwest Michigan, PC

    Grand Rapids, Michigan, 49546

    Julie Burns, 616-954-5559, julie.burns@startmidwest.com

    Leland Rouse, leland.rouse@startmidwest.com

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Emily Scott, (713) 745-2243, EMScott1@mdanderson.org

    David Hong, MD

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Carla Collier, carla.collier@valkyrieclinicaltrials.com

    David Berz, MD

    Recruiting

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232

    Samrah Ahmed, 615.936.9598, samrah.ahmed@vumc.org

    Elizabeth Davis, MD

    Recruiting

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

    New York, New York, 10021

    Care Advisors, 833-675-5437

    Emily Slotkin, MD

    Recruiting

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

    Orange, California, 92868

    Dorian Chan Clinical Research Nurse Coordinator, RN, BSN, 714-509-7868, dchan@choc.org

    Claudia Mousa, RN, 714-509-7868, Claudia.Mousa@choc.org

    Recruiting

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

    Philadelphia, Pennsylvania, 19104

    Matthew Stein, 267-425-3169, steinm3@chop.edu

    precisionmedicinetrialscoordinators@chop.edu

    Recruiting

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19106

    Sarcoma Research, SarcomaResearch@uphs.upenn.edu

    Lee Hartner, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Zach Nelson, 503-494-0833, nelsonz@ohsu.edu

    Michael Heinrich, MD

    Recruiting

  • NEXT Oncology

    San Antonio, Texas, 78229

    Completed

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

    San Diego, California, 92093

    Withdrawn

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94110

    Lisa Tan, 415-866-7866, lisa.tan@ucsf.edu

    Varun Monga, MD

    Recruiting

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

    Victoria Chua-Alcala, 310-552-9999, vchua@sarcomaoncology.com

    Sant P Chawla, MD

    Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

    Completed

Other trials in United States

United Kingdom4 sites, 4 recruiting

  • Great North Children's Hospital

    London, EC4V 3BJ

    Quentin Campbell-Hewson, MD

    Recruiting

  • University College London Hospital

    London, NW1 2PG

    Sandra Strauss, MD

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

    Andrea Napolitano, MD

    Recruiting

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL

    Bernadette Maria Dymphna Brennan

    Recruiting

Other trials in United Kingdom

Spain3 sites, 3 recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

    Elena Elez, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Ana Sebio Garcia, MD

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Antonio Casado Herraez

    Recruiting

Other trials in Spain

France2 sites, 2 recruiting

  • Centre Leon Berard

    Lyon, 69008

    Mehdi Brahmi, MD

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Pablo Berlanga, MD

    Recruiting

Other trials in France

Italy2 sites, 2 recruiting

  • La Fondazione e l'Istituto di Candiolo

    Candiolo, 10060

    Sandra Aliberti, MD

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20123

    Salvatore Provenzano, MD

    Roberto Luksch, MD

    Recruiting

Other trials in Italy

Netherlands2 sites, 2 recruiting

  • University Medical Center Groningen

    Groningen

    Jacco de Haan, MD

    Recruiting

  • Academisch Ziekenhuis Leiden

    Leiden

    André (Hans) Gelderblom, MD

    Recruiting

Other trials in Netherlands

About this study

Official title: 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).

Being tested
INBRX-109, Irinotecan, Temozolomide, carboplatin, pemetrexed
Keywords
Phase 1, Phase 1 Clinical Trial, Solid Tumors, Sarcoma, DR5, Ewing Sarcoma, CRC, colorectal adenocarcinoma
Medical subject headings
Sarcoma, Ewing, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03715933
Study groupRoleWhat they receive
Dose Escalation (Complete)ExperimentalINBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
Receives: Drug: INBRX-109
Expansion Malignant Pleural Mesothelioma (Complete)ExperimentalSubjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Receives: Drug: INBRX-109
Expansion Gastric Adenocarcinoma (Complete)ExperimentalSubjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Receives: Drug: INBRX-109
Expansion Colorectal Adenocarcinoma (Complete)ExperimentalSubjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Receives: Drug: INBRX-109
Expansion Sarcomas (Complete)ExperimentalSubjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Receives: Drug: INBRX-109
Combination Expansion Malignant Pleural Mesothelioma (Complete)ExperimentalSubjects with malignant pleural mesothelioma will be treated with INBRX-109 in combination with chemotherapies (carboplatin, cisplatin, carboplatin and pemetrexed, or cisplatin and pemetrexed)
Receives: Drug: INBRX-109; Drug: carboplatin; Drug: pemetrexed
Combination Expansion Pancreatic Adenocarcinoma (Complete)ExperimentalSubjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
Receives: Drug: INBRX-109; Drug: Irinotecan; Drug: Leucovorin; Drug: Fluorouracil
Combination Expansion Adult Ewing SarcomaExperimentalAdult subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Receives: Drug: INBRX-109; Drug: Irinotecan; Drug: Temozolomide
Combination Expansion Colorectal Adenocarcinoma (Complete)ExperimentalSubjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
Receives: Drug: INBRX-109; Drug: Irinotecan; Drug: Leucovorin; Drug: Fluorouracil
Expansion Solid Tumors (Complete)ExperimentalSubjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Receives: Drug: INBRX-109
Combination Expansion SDH-deficient solid tumors or GIST (Complete)ExperimentalSubjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
Receives: Drug: INBRX-109; Drug: Temozolomide
Combination Expansion Colorectal Adenocarcinoma patients with FOLFIRI plus bevacizumabExperimentalColorectal adenocarcinoma will be treated with INBRX-109 with FOLFIRI (FU, leucovorin, and irinotecan) plus bevacizumab
Receives: Drug: INBRX-109; Drug: Irinotecan; Drug: Leucovorin; Drug: Fluorouracil; Drug: Bevacizumab
Combination Expansion Colorectal Adenocarcinoma with FTD/TPI plus bevacizumabExperimentalColorectal adenocarcinoma will be treated with INBRX-109 with FTD/TPI plus bevacizumab
Receives: Drug: INBRX-109; Drug: Bevacizumab; Drug: Trifluridine + Tipiracil
Combination Expansion Adolescent Ewing SarcomaExperimentalAdolescent (12 to <18) subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Receives: Drug: INBRX-109; Drug: Irinotecan; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of adverse events of INBRX-109

    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.

    Measured: Up to 8 years

  2. Evaluating Tumor Response for colorectal cancers and Ewing sarcoma

    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.

    Measured: Up to 8 years

Secondary outcomes (3)

  1. Immunogenicity of INBRX-109

    Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.

    Measured: Up to 8 years

  2. Characterize the pharmacokinetics of INBRX-109 as a single agent, and of INBRX-109 in combination with distinct chemotherapies.

    A measurement which indicates how the body processes INBRX-109 and how long it stays in the system.

    Measured: Up to 8 years

  3. Median progression-free survival for colorectal adenocarcinoma and Ewing sarcoma.

    Progression-free survival is defined as the time from start of study treatment until documented disease progression or death.

    Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2018
  2. Study start8 Oct 2018
  3. Primary completionDec 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
411 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03715933
Sponsor's protocol ID
Ph1 INBRX-109
Status last verified
May 2026
First submitted
11 Oct 2018
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Subbiah V, Chawla SP, Conley AP, Wilky BA, Tolcher A, Lakhani NJ, Berz D, Andrianov V, Crago W, Holcomb M, Hussain A, Veldstra C, Kalabus J, O'Neill B, Senne L, Rowell E, Heidt AB, Willis KM, Eckelman BP. Preclinical Characterization and Phase I Trial Results of INBRX-109, A Third-Generation, Recombinant, Humanized, Death Receptor 5 Agonist Antibody, in Chondrosarcoma. Clin Cancer Res. 2023 Aug 15;29(16):2988-3003. doi: 10.1158/1078-0432.CCR-23-0974.

    PubMed 37265425

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INBRX-109, Irinotecan and Temozolomide in people with Ewing Sarcoma and Colorectal Adenocarcinoma, run by Inhibrx Biosciences, Inc at 37 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, United Kingdom, Spain, France, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director, -Inhibrx (858-500-7833, clinicaltrials@inhibrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of adverse events of INBRX-109 (time frame: Up to 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03715933, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in