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
Inhibrx Biosciences, Inc
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).
Eligibility
- Age range
- 12–85 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugINBRX-109
Tetravalent DR5 Agonist Antibody
- DrugIrinotecan
Chemotherapy
- DrugTemozolomide
Chemotherapy
- Drugcarboplatin
chemotherapy
- Drugpemetrexed
chemotherapy
- DrugLeucovorin
chemotherapy
- DrugFluorouracil
chemotherapy
Locations (35)
- HonorHealth Research InstituteScottsdale, Arizona
- Precision NextGen Oncology and ResearchBeverly Hills, California
- City of HopeDuarte, California
- Valkyrie Clinical TrialsLos Angeles, California
- University of California, San Diego (UCSD) - Moores Cancer CenterSan Diego, California
- University of California, San Francisco (UCSF)San Francisco, California