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

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Melanoma
• Metastatic Lung Cancer
• Metastatic Melanoma
• Metastatic Non Small Cell Lung Cancer
• Non Small Cell Lung Cancer
• Tumor Skin

• 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