A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors
brief summary
Phase 1 is to find the recommended dose of KSQ-004EX to give to participants with advanced solid tumors. Phase 2 is to learn if KSQ-004EX at the recommended dose found in Phase1 can help to control advanced solid tumors. The safety and effects of KSQ-004EX will also be studied in both phases.
detailed description
Phase 1: Dose Escalation
Primary Objective:
* To evaluate the safety and tolerability of KSQ-004EX in adult participants with advanced solid tumors (melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer) Secondary Objectives * Determine expansion dose * Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors (melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer) * Evaluate preliminary anti-tumor activity of KSQ-004EX in participants with advanced solid tumors * Evaluate the feasibility of the manufacturing process
Phase 2: Expansion Primary Objective
* To assess the anti-tumor activity of KSQ-004EX in participants with advanced malignant solid tumors Secondary Objectives * Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors (melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer) * Evaluate anti-tumor activity of KSQ-004EX in participants with advanced malignant solid tumors * Evaluate overall survival (OS) * Evaluate the feasibility of the manufacturing process