A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Solid tumour 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 tumour does not always imply cancer. In discussing tumours that are malignant (cancerous), however, the term solid tumour is used to distinguish between a localised mass of tissue and leukaemia.
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-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors
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.
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
