Home › Trials › NCT03715933

Testing INBRX-109 for advanced 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

Phase 1 Interventional Inhibrx Biosciences, Inc · NCT03715933

This study is testing a new treatment called INBRX-109 for people with advanced solid tumors, like Ewing sarcoma and colorectal cancer, to see how safe it is and if it works better with standard chemotherapy.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment321 (estimated)
Ages12 Years to 85 Years
SexAll
SponsorInhibrx Biosciences, Inc Industry-sponsored
Drugs / interventionschemotherapy
Locations35 sites (Scottsdale, Arizona and 34 other locations)
Trial IDNCT03715933 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label, non-randomized phase 1 trial evaluating the safety and efficacy of INBRX-109, a recombinant humanized tetravalent antibody that targets the human death receptor 5 (DR5). The study involves three parts and includes patients with locally advanced or metastatic solid tumors, specifically Ewing sarcoma and colorectal adenocarcinoma. Participants will receive INBRX-109 in combination with standard chemotherapy agents such as Carboplatin, Cisplatin, Pemetrexed, and 5-fluorouracil. The trial aims to determine the maximum tolerated dose and assess the drug's potential therapeutic effects.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 12 to 85 with locally advanced or metastatic Ewing sarcoma or colorectal adenocarcinoma who have received limited prior treatments.

Not a fit: Patients with early-stage tumors or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.

How similar studies have performed: Other studies targeting death receptor pathways have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
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, or irinotecan
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.

Where this trial is running

Scottsdale, Arizona and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ewing SarcomaPhase 1Phase 1 Clinical TrialSolid TumorsSarcomaDR5
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.