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Phase 1 Study of INBRX-109 for Solid Tumors and Sarcomas

This is a Phase 1 study testing a new drug called INBRX-109, which is a type of antibody that targets a specific protein (death receptor 5 or DR5) on cancer cells. It's being studied in people with advanced solid tumors, including Ewing sarcoma and colorectal cancer. Researchers are also looking at INBRX-109 when given with chemotherapy drugs like Irinotecan, Temozolomide, Carboplatin, or Pemetrexed. The main goals are to see how safe INBRX-109 is and how well it works to shrink tumors. This study is open to people aged 12 to 85 years old with specific types of cancer that have not responded to other treatments.

Study design
This is a Phase 1, open-label (meaning you and your doctors will know what treatment you are receiving), non-randomized study. It plans to enroll up to 411 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to 8 years to monitor for side effects and tumor response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03715933

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

Recruiting
PHASE1Ages 12–85InterventionalTreatment
Inhibrx Biosciences, Inc
~411 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:INBRX-109IrinotecanTemozolomidecarboplatinpemetrexedLeucovorin

At a glance

Recruiting sites
31 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and severity of adverse events of INBRX-109
Measured over Up to 8 years
+1 more outcome measured

Conditions

Ewing Sarcoma
Colorectal Adenocarcinoma

Explore related trials

Colorectal AdenocarcinomaEwing SarcomaSarcomaSolid Neoplasm

Where it's being run

36 sites across 18 states
California6
United Kingdom4
Spain3
Michigan2
Ohio2
Pennsylvania2
Texas2
Virginia2

Study leadership

  • Clinical Lead · STUDY_DIRECTOR · Inhibrx Biosciences, Inc

Who to contact

Study Director, -Inhibrx
[email protected]
858-500-7833
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

What this trial measures

  • Frequency and severity of adverse events of INBRX-109Up 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.

  • Evaluating Tumor Response for colorectal cancers and Ewing sarcomaUp 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.