# ETX-636

Source: https://onco.cc/drugs/etx-636/  
OnCo record `etx-636` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-11-03
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- Ensem Therapeutics: ensemtx.com: https://ensemtx.com/science/pipeline/
- Ensem Therapeutics: clinicaltrials.gov: https://clinicaltrials.gov/api/v2/studies/NCT06993844
- Ensem Therapeutics: ensemtx.com: https://ensemtx.com/news/
- ClinicalTrials.gov: trials of ETX-636: https://clinicaltrials.gov/search?intr=ETX-636

## Connected records

- cancers: [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/)
- targets: [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/)
- companies: [Ensem Therapeutics](https://onco.cc/companies/ensem-therapeutics/)
- trials: [Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct06993844/)

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JSON: https://onco.cc/api/v1/entities/etx-636.json