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New pill shows promise against Hard-to-Treat cancers

NCT ID NCT06993844

First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 31 times

Summary

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

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Beijing Luhe Hospital,Capital Medical University

    RECRUITING

    Beijing, China

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Carolina BioOncology Institute

    RECRUITING

    Huntersville, North Carolina, 28078, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact Phone: •••-•••-••••

    Contact

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Fudan University Shanghai Cancer Hospital

    RECRUITING

    Shanghai, China

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • NEXT

    RECRUITING

    Fairfax, Virginia, 22031, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • START

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Shandong Cancer Hospital&Institute

    RECRUITING

    Shandong, China

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, China

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Phone: •••-•••-••••

    Contact

  • UCSF Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Yale University, Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

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 specific cancer-driving protein, taken as a pill once daily, sometimes combined with fulvestrant)

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), potentially shrinking tumors or slowing their growth.

What could go wrong

This is a very early (first-in-human) trial, so the drug may not work as hoped or could cause unexpected side effects. Only a small number of participants will receive the drug initially, and results may not apply to all patients.

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.