Tests INBRX-109 in people with advanced solid tumors, including sarcomas

Trial details

Who runs it

Inhibrx Biosciences, Inc

Trial code

NCT03715933EU 2023-508139-29-00

Record updated

8 September 2026

Original description

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 full original descriptionShow less

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).

Inclusion: 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; 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.

Exclusion: 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; 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; Acute viral or toxic liver disease within 12 months prior to the first dose of study drug; 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; Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies; 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; Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; 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; Other exclusion criteria per protocol.

ClinicalTrials.gov NCT03715933 · EU CTIS 2023-508139-29-00