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