New pill targets Hard-to-Treat cancers with specific gene mutation

NCT ID NCT06993844

Recruiting now Disease control Sponsor: Ensem Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new daily pill, ETX-636, for people with advanced solid tumors (including breast cancer) that have a specific genetic change called PIK3CA. The trial has two parts: first, finding a safe dose of ETX-636 alone or with another drug (fulvestrant); second, checking if the combination shrinks tumors. About 233 participants will join this early-stage study to see if the drug is safe and shows promise.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ETX-636 (a targeted drug that blocks a mutated protein called PI3Kα, taken as a daily pill)
What this could lead to: If successful, this could lead to a new treatment option for people with advanced solid tumors that have a specific genetic mutation (PIK3CA).
What could go wrong: This is an early, first-in-human study, so the drug may not work as hoped or could cause unexpected side effects. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast disorder breast neoplasm endometrium neoplasm Head and Neck Neoplasms hereditary sensory and autonomic neuropathy hormone receptor-positive breast cancer neoplasm Neoplasms by Site ovarian cancer Squamous Cell Carcinoma of Head and Neck Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED BREAST CANCER ADVANCED SOLID TUMORS

Contacts and locations

Locations

Beijing Luhe Hospital,Capital Medical University
RECRUITING

Beijing, China
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02215, United States
Carolina BioOncology Institute
RECRUITING

Huntersville, North Carolina, 28078, United States
Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Fred Hutchinson Cancer Center
RECRUITING

Seattle, Washington, 98109, United States
Fudan University Shanghai Cancer Hospital
RECRUITING

Shanghai, China
Fujian Cancer Hospital
RECRUITING

Fuzhou, China
Hoag Memorial Hospital Presbyterian
RECRUITING

Newport Beach, California, 92663, United States
NEXT
RECRUITING

Fairfax, Virginia, 22031, United States
START
RECRUITING

San Antonio, Texas, 78229, United States
Shandong Cancer Hospital&Institute
RECRUITING

Shandong, China
Sun Yat-sen University Cancer Center
RECRUITING

Guangzhou, China
The University of Texas MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITING

San Francisco, California, 94158, United States
Yale University, Yale Cancer Center
RECRUITING

New Haven, Connecticut, 06520, United States

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