Trial Profile

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 19 Mar 2026

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At a glance

Drugs ETX 636 (Primary) ; Fulvestrant (Primary)
Indications Advanced breast cancer; HER2 negative breast cancer; Solid tumours
Focus Adverse reactions; First in man; Therapeutic Use
Sponsors ENSEM Therapeutics

02 Feb 2026 According to Ensem Therapeutics media release,company expects to disclose preliminary clinical data supporting proof of concept in the second half of 2026.
02 Feb 2026 According to Ensem Therapeutics media release, first patient has been dosed in China.
01 Jul 2025 According to Ensem Therapeutics media release, first patient has been dosed in phase 1/2 study of ETX-636 at START San Antonio (Amita Patnaik, M.D.).

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