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New pill targets Hard-to-Treat cancers in early human trial

NCT ID NCT06799065

Disease control Sponsor: Accent Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 17, 2026 · Updated 6 times

Summary

This study is testing an experimental oral drug called ATX-295 in people with advanced solid tumors, including ovarian cancer, that have not responded to standard treatments. The main goal is to find a safe and tolerable dose and to see if the drug can shrink tumors. About 90 participants will take part in this first-in-human trial.

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

Mar 2025

Expected to finish

Aug 2027

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.

Key Inclusion Criteria: * Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC * Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit * For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant * There is no limit to the number of prior treatment regimens * Have measurable or evaluable disease * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Key Exclusion Criteria: * Clinically unstable central nervous system (CNS) tumors or brain metastasis * Any other concurrent anti-cancer treatment, except for hormonal blockade * Has undergone a major surgery within 3 weeks of starting study treatment * Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial * Clinically significant (ie, active) or uncontrolled cardiovascular disease * Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study. * Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers * Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment Other inclusion and exclusion criteria as defined in the study protocol

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Conditions

The condition(s) this trial relates to.

breast cancer metastatic malignant neoplasm neoplasm ovarian cancer ovarian serous adenocarcinoma triple-negative breast carcinoma

As listed by the trial registrant

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

Advanced solid tumors Breast cancer recurrent High-grade serous ovarian carcinoma Ovarian cancer Triple-negative breast cancer

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

    9 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

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • NYU Longone Health

    RECRUITING

    New York, New York, 10016, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • University of Colorado Denver

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

More trials for these conditions

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