A Phase 1 interventional study of INBRX-109 and Irinotecan in Ewing Sarcoma and Colorectal Adenocarcinoma, sponsored by Inhibrx Biosciences, Inc. Recruiting at 37 sites in 6 countries. Open to participants aged 12 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Inhibrx Biosciences, Inc · Phase 1, Interventional, and Treatment
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).
Part 3 combination therapy expansion tumor types:
Exclusion Criteria:
Known sensitivity or contraindications to the following drugs:
INBRX-109 will be escalated (3+3 design) in subjects with locally advanced or metastatic solid tumors including sarcomas.
Drug: INBRX-109
Subjects with malignant pleural mesothelioma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Subjects with gastric adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Subjects with colorectal (CRC) adenocarcinoma will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Subjects with certain sarcoma subtypes will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
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 · Drug: carboplatin · Drug: pemetrexed
Subjects with pancreatic adenocarcinoma will be treated with INBRX-109 in combination with 5FU/irinotecan based chemotherapy
Drug: INBRX-109 · Drug: Irinotecan · Drug: Leucovorin · Drug: Fluorouracil
Adult subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Drug: INBRX-109 · Drug: Irinotecan · Drug: Temozolomide
Subjects with colorectal adenocarcinoma will be treated with INBRX-109 in combination with FOLFIRI based chemotherapy
Drug: INBRX-109 · Drug: Irinotecan · Drug: Leucovorin · Drug: Fluorouracil
Subjects with Solid tumors and high BMI will be treated with single-agent INBRX-109 at either the MTD or RP2D.
Drug: INBRX-109
Subjects with SDH-deficient solid tumors or GIST will be treated with INBRX-109 in combination with temozolomide
Drug: INBRX-109 · Drug: Temozolomide
Colorectal adenocarcinoma will be treated with INBRX-109 with FOLFIRI (FU, leucovorin, and irinotecan) plus bevacizumab
Drug: INBRX-109 · Drug: Irinotecan · Drug: Leucovorin · Drug: Fluorouracil · Drug: Bevacizumab
Colorectal adenocarcinoma will be treated with INBRX-109 with FTD/TPI plus bevacizumab
Drug: INBRX-109 · Drug: Bevacizumab · Drug: Trifluridine + Tipiracil
Adolescent (12 to \<18) subjects with Ewing Sarcoma will be treated with INBRX-109 in combination with irinotecan and temozolomide
Drug: INBRX-109 · Drug: Irinotecan · Drug: Temozolomide
Tetravalent DR5 Agonist Antibody
Chemotherapy
Chemotherapy
chemotherapy
chemotherapy
chemotherapy
chemotherapy
targeted therapy
chemotherapy
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.
Time frame: Up to 8 years
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.
Time frame: Up to 8 years
Immunogenicity of INBRX-109
Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined.
Time frame: Up to 8 years
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.
Time frame: Up to 8 years
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.
Time frame: Up to 8 years
Anti-tumor activity of INBRX-109
Tumor response will be determined by RECISTv1.1.
Time frame: Up to 8 years
Potential predictive response biomarkers
Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109
Time frame: Up to 8 years
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Inhibrx Biosciences, Inc