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Brief Title: Safety and Efficacy of OBX-115 in Advanced Solid Tumors
Official Title: 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
Study ID: NCT06060613
Brief Summary: This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.
Detailed 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 the investigator using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Secondary (Phase 1): • Assess preliminary efficacy of OBX-115 regimen by evaluating ORR Secondary (Phase 2): • Evaluate safety and tolerability of OBX 115 based on the collected AE data Secondary (both Phase 1 and Phase 2): * Evaluate duration of response (DOR): To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to cancer. * Evaluate disease control rate (DCR): To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) for at least 4 weeks per RECIST v1.1 as assessed by the investigator. * Evaluate progression-free survival (PFS): To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause. * Evaluate overall survival (OS): To evaluate the time from the date of OBX-115 infusion to death due to any cause * Evaluate feasibility of the manufacturing process: Evaluated as the proportion of OBX-115 products initiated for manufacturing that pass release criteria for infusion.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Orlando Health Cancer Institute (Melanoma), Orlando, Florida, United States
James Graham Brown Cancer Center (Melanoma/NSCLC), Louisville, Kentucky, United States
Memorial Sloan Kettering (Melanoma/NSCLC), New York, New York, United States
Allegheny Research Institute, Pittsburgh, Pennsylvania, United States