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Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Lung Cancer Clinical Trial

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

Clinical Trial Summary

This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06060613
Study type Interventional
Source Obsidian Therapeutics, Inc.
Contact Obsidian Therapeutics
Phone 781-202-5423
Email OBX115-2301TRIAL@OBSIDIANTX.COM
Status Recruiting
Phase Phase 1/Phase 2
Start date October 25, 2023
Completion date October 30, 2027
View Details
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