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 Sep 2025

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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

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.).
05 Jun 2025 Planned initiation date changed from 29 May 2025 to 6 Jun 2025.
05 Jun 2025 Status changed from not yet recruiting to recruiting.

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