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: 12 Jun 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

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.
23 Apr 2025 According to Ensem Therapeutics media release, the company announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for ETX-636, and the study is anticipated in the second quarter of 2025.

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