Clinical trialPhase 1 / Phase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 21 November 2024
- Expected end
- 1 August 2041
- Enrollment
- 141 participants
- Sites
- 1
- Primary outcomes
- Safety and adverse events (AEs)
- Sponsor
- Other
- Results posted
- No
- Last update
- 2 November 2026
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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