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New targeted pill takes aim at Hard-to-Treat cancers

NCT ID NCT07383506

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This early-stage trial tests a daily oral drug called CGT6297 in 90 adults with advanced solid tumors that have a specific mutation in the PIK3CA gene. The study has two parts: first, finding a safe dose, and then looking for signs that the drug shrinks tumors. It focuses on people with endometrial cancer or certain types of breast cancer.

What this could mean

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

Active substance
CGT6297 (a daily oral pill that targets a specific cancer-driving mutation)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced cancers that have a PIK3CA mutation, especially endometrial and breast cancers.
What could go wrong
This is a very early Phase 1 trial with only 90 participants, so the drug may not prove safe or effective. Side effects are unknown, and many early cancer drugs fail to advance.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and/or tumor: 1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer 2. Phase 1b Cohort 2, participants must have HR-positive/HER2-negative or HER2-low breast cancer (immunohistochemistry \[IHC\] and in-situ hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria) 3. Phase 1b Cohort 3 will allow all solid tumors that do not meet criteria for Phase 1b Cohorts 1 or 2, including head and neck cancers, other gynecological cancers, colorectal cancers harboring PIK3CA mutations 2. Meet prior treatment requirement of: 1. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. 2. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition 3. Have at least one measurable lesion according to RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits 6. Resolution of acute toxicities from prior anticancer therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities (other than parameters specified in screening testing as outlined below), as determined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) v5.0. 7. Have an ejection fraction ≥50% Exclusion Criteria: 1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug. 2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug 3. Treatment with radiotherapy ≤2 weeks before the first dose of study drug. 4. Clinically significant cardiac disease 5. Ongoing or planned long-term (≥4 consecutive weeks) treatment with glucocorticoid steroids at greater than physiologic dosing (defined as equivalent to \>20 mg/day prednisone) 6. Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg/dL and HbA1c ≥7.0%; antihyperglycemic medical management permitted with the exception of insulin) 7. Previous molecular testing (NGS or PCR) showed tumor with the following mutations: mutations/deletions in PTEN or activating mutations in AKT, HRAS/KRAS/NRAS, EGFR, and BRAF

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Conditions

The condition(s) this trial relates to.

breast neoplasm endometrial cancer endometrium neoplasm hormone receptor-positive breast cancer neoplasm

As listed by the trial registrant

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

Advanced solid tumors, adult Endometrial cancer HER2 low breast cancer HR positive/HER-2 negative breast cancer PIK3CA mutations

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

    RECRUITING

    Tampa, Florida, 33612, United States

  • HonorHealth Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • NEXT Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • SCRI Oncology Partners - Nashville

    RECRUITING

    Nashville, Tennessee, 01071, United States

  • START Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

  • START Mountain Region, LLC

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START New Jersey, LLC

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Sarah Cannon Research Institute (SCRI) at HealthONE-Denver

    RECRUITING

    Denver, Colorado, 80218, United States

  • Washington University School of Medicine - Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.