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New pill targets Hard-to-Treat cancers with brain spread

NCT ID NCT07361562

Recruiting now Disease control Sponsor: Cogent Biosciences, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a daily oral drug called CGT4255 in 100 adults with advanced solid tumors that have ERBB2 genetic changes or HER2 overexpression. The main goals are to check safety, find the right dose, and see if the drug shrinks tumors, including in the brain. The trial includes people with certain lung and breast cancers that have spread to the brain.

What this could mean

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

Active substance
CGT4255 (a daily oral drug that targets ERBB2 and HER2)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced cancers that have specific genetic changes, including some lung and breast cancers that have spread to the brain.
What could go wrong
This is an early Phase 1 trial with only 100 participants, so the drug may not prove safe or effective. Side effects are unknown, and it may not work for all tumor types.

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.

HER2 positive breast carcinoma non-small cell lung carcinoma

As listed by the trial registrant

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

ADVANCED SOLID TUMOR, ADULT ERBB2 ALTERED BREAST CANCER ERBB2 GENE AMPLIFICATION HER2 HER2 OVEREXPRESSION NON-SMALL CELL LUNG CANCER

Contacts and locations

Study contacts

  • Contact

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

Locations

  • NEXT Oncology Texas

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

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