KSQ Therapeutics has commenced a Phase 1/2 clinical trial (NCT06598371) to investigate the safety, tolerability, and anti-tumor activity of KSQ-004EX in adult participants with advanced solid tumors. The study, which is currently not yet recruiting, aims to determine the recommended dose of KSQ-004EX and assess its potential in controlling advanced malignancies, including melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), pancreatic cancer, and cervical cancer.
Phase 1: Dose Escalation and Safety Evaluation
The Phase 1 portion of the trial is designed as a dose-escalation study to evaluate the safety and tolerability of KSQ-004EX. Adult participants with advanced solid tumors, specifically melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer, will be enrolled. The primary objective is to determine the recommended dose for further studies. Secondary objectives include assessing the safety profile, evaluating preliminary anti-tumor activity, and assessing the feasibility of the manufacturing process.
Phase 2: Expansion and Anti-Tumor Activity Assessment
Following the dose escalation phase, Phase 2 will focus on assessing the anti-tumor activity of KSQ-004EX at the recommended dose in participants with advanced malignant solid tumors. The primary objective is to evaluate the drug's ability to control tumor growth. Secondary objectives include further assessment of safety and tolerability, evaluation of overall survival (OS), and continued evaluation of the manufacturing process feasibility. The study will enroll patients with melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer.
The trial's design incorporates comprehensive monitoring of safety and efficacy endpoints across both phases, providing a thorough evaluation of KSQ-004EX's potential as a novel therapeutic option for patients with advanced solid tumors. The last updated information for this trial was on November 2, 2024.
