A solid tumor is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancer), or malignant (cancer). Solid tumor types are named according to the type of cell they originate from. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours.
This trial is specifically targeting patients with melanoma, head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC).
The word tumor does not always imply cancer. In discussing tumors that are malignant (cancerous), however, the term solid tumor is used to distinguish between a localized mass of tissue and leukemia.
Frequency:
More than 1.9 million new cancer cases are expected to be diagnosed in the US in 2023.
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
Who:
Contact
Name: Rodabe N Amaria, MD
Phone: (713) 792-2921
Email: rnamaria@mdanderson.org
Sponsor:
M.D. Anderson Cancer Center
Partners:
KSQ Therapeutics, Inc.
Locations:
Texas, United States MD Anderson Cancer Center, Houston, Texas, United States, 77030
The objective of this trial is to learn if KSQ-001EX is safe to give to participants with advanced forms of solid tumors. Phase I primary objectives are to evaluate the safety and tolerability of KSQ-001EX in adult participants with advanced solid tumors (melanoma, HNSCC, NSCLC).
Phase I primary endpoint is incidence of dose-limiting toxicities (DLTs)
Phase I secondary objectives are to 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, and evaluate the feasibility of the manufacturing process. Phase I secondary endpoints are 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, and manufacturing success rate.
Phase 2 primary objectives are to assess the anti-tumor activity of KSQ-001EX in patients with advanced malignant solid tumors. Phase 2 primary endpoint is ORR per RECIST v1.1
Phase 2 secondary objectives are to 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 are 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, and manufacturing success rate.
Phase 1/2 exploratory objectives include to 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 are KSQ-001EX levels in blood and tumor tissue, change from Baseline in soluble immune factors, lymphocytes and immune markers, and KSQ-001EX pharmacodynamic markers, KSQ-001EX DP release criteria, and KSQ-001EX persistence.
