{"entity":{"id":"mtx-531","kind":"drug","name":"MTX-531","aka":[],"tldr":"MTX-531 is an experimental small molecule from MEKanistic Therapeutics, in phase 1 trials for head and neck squamous cell carcinoma, endometrial cancer and HER2-negative metastatic breast cancer and other cancers.","summary":"MTX-531 is a small molecule (oral) from MEKanistic Therapeutics. A computationally designed small molecule that inhibits both EGFR and PI3K; the company says PPAR-gamma agonist activity reduces the hyperglycaemia expected from PI3K inhibition. Its furthest stage is phase 1, for head and neck squamous cell carcinoma, endometrial cancer, HER2-negative metastatic breast cancer and RAS and BRAF wild-type metastatic colorectal cancer. ClinicalTrials.gov registers it in one study linked below. Phase 1 NCT07874880 not yet recruiting (registry, first posted 15 Oct 2026). Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"MEKanistic Therapeutics: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT07874880"},{"label":"MEKanistic Therapeutics: mekanistic.com","url":"https://www.mekanistic.com/pipeline.html"},{"label":"MEKanistic Therapeutics: mekanistic.com","url":"https://www.mekanistic.com/"},{"label":"ClinicalTrials.gov: trials of MTX-531","url":"https://clinicaltrials.gov/search?intr=MTX-531"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["head-and-neck","endometrial","breast-cancer","colorectal","metastatic-cancer"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":["mekanistic-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07874880"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"MTX-531","modality":"Small molecule (oral)","mechanism":"A computationally designed small molecule that inhibits both EGFR and PI3K; the company says PPAR-gamma agonist activity reduces the hyperglycaemia expected from PI3K inhibition.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/mtx-531/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"mekanistic-therapeutics","kind":"company","name":"MEKanistic Therapeutics","route":"/companies/mekanistic-therapeutics/"}],"trial":[{"id":"nct07874880","kind":"trial","name":"MTX-531-001 Phase 1 Study in Advanced Solid Tumors","route":"/trials/nct07874880/"}]}}