Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 15, 2026
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Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07874880). This is a study registration, not published results. Lead sponsor: MEKanistic Therapeutics, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 71 participants (ESTIMATED). Conditions: Solid Tumors (Phase 1), HNSCC, Endometrial Cancer, Her2-negative Metastatic Breast Cancer, Pan-RAS and BRAF Wild-type Advanced, Metastatic Colorectal Cancer (CRC), Head and Neck Squamous Cell Carcinoma. Interventions: DRUG: MTX-531. Primary outcome measures: Safety and Tolerability profile of MTX-531 , From the time of first dose of study drug administration up to 21 days.; Provisional RP2D For Further Evaluation of MTX-531 , From the time of first dose of study drug administration to 30 days after the last dose. Brief summary: This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors. The study will evaluate the safety and tolerability of MTX-531, determine the maximum tolerated dose and recommended Phase 2 dose, and assess how the drug is processed by the body and its preliminary anti-tumor activity.