A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants With Advanced Solid Tumors
Obsidian Therapeutics, Inc.
Summary
This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
Description
Primary Objective (Phase 1): • Assess the safety and tolerability of OBX-115 regimen Primary Objective (Phase 2): * Evaluate preliminary efficacy of OBX-115 regimen as measured by Blinded Independent Central Review (BICR) using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Cohort 3) * Evaluate preliminary efficacy of OBX-115 regimen as measured by the investigator using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Cohorts 1, 2, 4) Secondary (Phase 1): • Assess preliminary efficacy of OBX-115 r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant must be 18 years of age or older at the time of signing the informed consent. 2. Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC). 3. Cohort and indication specific criteria as follows: 1. Phase 1 and Phase 2 Cohort 1 (enrollment complete): * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed…
Interventions
- BiologicalOBX-115
A tumor sample is obtained from each participant for autologous OBX-115 manufacture. After lymphodepletion including cyclophosphamide and fludarabine, participant will receive OBX-115 infusion, followed by short courses of acetazolamide.
Locations (9)
- The Angeles Clinic and Research Institute (Melanoma)Los Angeles, California
- USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)Los Angeles, California
- Stanford Cancer Institute (Melanoma/NSCLC)Stanford, California
- Orlando Health Cancer Institute (Melanoma/NSCLC)Orlando, Florida
- James Graham Brown Cancer Center (Melanoma/NSCLC)Louisville, Kentucky
- Memorial Sloan Kettering (Melanoma/NSCLC)New York, New York