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A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors

Melanoma Clinical Trial

Official title:
A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors

Clinical Trial Summary

To learn if KSQ-001EX is safe to give to participants with advanced forms of solid tumors.

Clinical Trial Description

Phase I Primary Objectives • To evaluate the safety and tolerability of KSQ-001EX in adult participants with advanced solid tumors (melanoma, HNSCC, NSCLC) Phase I Primary Endpoint • Incidence of dose-limiting toxicities (DLTs) Phase I Secondary Objectives - Determine expansion dose - Assess the safety and tolerability of KSQ-001EX in participants with advanced solid tumors (melanoma, HNSCC, NSCLC) - Evaluate preliminary antitumor activity of KSQ-001EX in participants with advanced solid tumors - Evaluate the feasibility of the manufacturing process. Phase I Secondary Endpoints - Incidence and severity of treatment-emergent adverse events (TEAEs) and change from Baseline in laboratory results - Objective response rate (ORR), duration of response (DOR), time to response (TTR) as assessed by the Investigator, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Manufacturing success rate Phase 2 Primary Objectives • To assess the anti-tumor activity of KSQ-001EX in patients with advanced malignant solid tumors Phase 2 Primary Endpoint • ORR per RECIST v1.1 Phase 2 Secondary Objectives - Assess the safety and tolerability of KSQ-001EX in patients with advanced solid tumors (melanoma, HNSCC, NSCLC) - Evaluate anti-tumor activity of KSQ-001EX in patients with advanced malignant solid tumors - Evaluate overall survival (OS) - Evaluate the feasibility of the manufacturing process Phase 2 Secondary Endpoints - Incidence and severity of TEAEs and change from Baseline in laboratory results - Complete response rate (CRR), DOR, TTR, progression-free survival (PFS) per RECIST v1.1 - OS - Manufacturing success rate Phase 1/2 Exploratory Objectives - Determine persistence of KSQ-001EX - Assess changes in immune and pharmacodynamic markers following KSQ-001EX infusion - Assess correlations of KSQ-001EX biomarkers and KSQ-001EX DP characteristics with safety, clinical activity, and KSQ-001EX persistence Phase 1/2 Exploratory Endpoints - KSQ-001EX levels in blood and tumor tissue - Change from Baseline in soluble immune factors, lymphocytes and immune markers - KSQ-001EX pharmacodynamic markers, KSQ-001EX DP release criteria, and KSQ-001EX persistence ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06237881
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Rodabe N Amaria, MD
Phone (713) 792-2921
Email rnamaria@mdanderson.org
Status Recruiting
Phase Phase 1/Phase 2
Start date January 31, 2024
Completion date January 1, 2029
View Details
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