NCT06060613

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Obsidian Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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 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 BICR until disease progression or death due to cancer (Phase 2 Cohort 3). * 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 (Phase 1 and Phase 2 Cohorts 1, 2, and 4). * 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 BICR (Phase 2 Cohort 3). * 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 (Phase 1 and Phase 2 Cohorts 1, 2, and 4). * 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 BICR or death due to any cause (Phase 2 Cohort 3). * 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 (Phase 1 and Phase 2 Cohorts 1, 2, and 4). * 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.

Conditions

• Tumor Skin
• Metastatic Melanoma
• Melanoma
• Lung Cancer
• Metastatic Lung Cancer
• Non Small Cell Lung Cancer
• Metastatic Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	OBX-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.

Timeline

• Start date: 2023-10-25
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2023-09-29
• Last updated: 2026-03-27

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study