{"entity":{"id":"etx-636","kind":"drug","name":"ETX-636","aka":[],"tldr":"ETX-636 is an experimental small molecule from Ensem Therapeutics, in phase 2 trials for advanced breast cancer and advanced solid tumours.","summary":"ETX-636 is a small molecule (oral tablet) from Ensem Therapeutics. An allosteric, pan-mutant-selective PI3K-alpha inhibitor and degrader, which the company says targets mutant PI3K-alpha without affecting glucose homeostasis. Its furthest stage is phase 2, for advanced breast cancer and advanced solid tumours. ClinicalTrials.gov registers it in one study linked below. Phase 1/2 NCT06993844, recruiting, started 10 June 2025; FDA Fast Track for advanced breast cancer (Oct 2025); first patient dosed in China Feb 2026 (Ensem news list). Whether it works in people has not been established unless a trial below reports it.","status":"phase-2","asOf":"2026-11-03","links":[{"label":"Ensem Therapeutics: ensemtx.com","url":"https://ensemtx.com/science/pipeline/"},{"label":"Ensem Therapeutics: clinicaltrials.gov","url":"https://clinicaltrials.gov/api/v2/studies/NCT06993844"},{"label":"Ensem Therapeutics: ensemtx.com","url":"https://ensemtx.com/news/"},{"label":"ClinicalTrials.gov: trials of ETX-636","url":"https://clinicaltrials.gov/search?intr=ETX-636"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["pik3ca"],"drugs":[],"companies":["ensem-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06993844"],"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":"ETX-636","modality":"Small molecule (oral tablet)","mechanism":"An allosteric, pan-mutant-selective PI3K-alpha inhibitor and degrader, which the company says targets mutant PI3K-alpha without affecting glucose homeostasis.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/etx-636/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"target":[{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"}],"company":[{"id":"ensem-therapeutics","kind":"company","name":"Ensem Therapeutics","route":"/companies/ensem-therapeutics/"}],"trial":[{"id":"nct06993844","kind":"trial","name":"Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors","route":"/trials/nct06993844/"}]}}