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New drug combo shows promise for Tough-to-Treat endometrial cancer

NCT ID NCT06463028

Disease control Sponsor: Faeth 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new combination of drugs (sapanisertib and serabelisib, together called PIKTOR) plus standard chemotherapy (paclitaxel) in people with advanced or recurrent endometrial cancer that has not been cured by prior treatments. The goal is to see if this combo can shrink tumors or slow the cancer. A small part of the study also looks at whether a special low-insulin diet can help the drugs work better. About 40 adults will take part.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Started

Dec 2024

Expected to finish

Sep 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

Female participants only

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: * Histologically confirmed diagnosis of endometrioid endometrial carcinoma. * Documented evidence of advanced or recurrent endometrial cancer that is not amenable to surgery/radiation for curative intent. * Participant has received at least 1 but not more than 4 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination. If a subject has been unable to be treated with checkpoint inhibitor in the past due to medical contraindications, consult with Medical Monitor. * PI3K/AKT/mTOR pathway gene alteration identified. * At least 1 measurable target lesion according to RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening. * Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.. Exclusion Criteria: * Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study * Active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas \[e.g., breast, cervix, bladder\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible. * Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment. * Clinically significant (per Investigator judgement) hemoptysis or tumor bleeding. * Significant cardiovascular impairment. * Active, uncontrolled (requiring systemic antimicrobial therapy) infection. * Concurrent participation in another therapeutic clinical trial. * Prior radiation therapy within 21 days prior to start of study treatment. * Strong CYP3A4 inhibitors and inducers are prohibited during the study. Strong CYP1A2 inhibitors as well as CYP1A2 inducers should be administered with caution and at the discretion of the Investigator. Alternative treatments, if available, should be considered. Additionally, strong CYP3A4 inhibitors or inducers should not be taken within 7 days before the first dose of study intervention. * Participants who require PPIs or chronic use of antacids, histamine H2 receptor blockers, or other treatments to raise gastric pH. * Prolongation of QTc interval to \>480 ms. * HbA1c ≥ 8.0% or fasting serum glucose \> 160 mg/dL or fasting triglycerides \> 300 mg/dL or receiving treatment with insulin.

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Conditions

The condition(s) this trial relates to.

Carcinoma, Endometrioid endometrial cancer endometrial endometrioid adenocarcinoma endometrium neoplasm Genital Diseases hereditary sensory and autonomic neuropathy

As listed by the trial registrant

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

Endometrial 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

    18 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

  • Alliance Cancer Specialists, PC

    RECRUITING

    Doylestown, Pennsylvania, 18901, United States

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Florida Cancer Specialists, East

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists, North

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Maryland Oncology Hematology, P.A.

    RECRUITING

    Brandywine, Maryland, 20613, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Minnesota Oncology Hematology, P.A.

    RECRUITING

    Maple Grove, Minnesota, 55369, United States

  • Mount Sinai Comprehensive Cancer Center

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • Northwest Cancer Specialists, P.C.

    RECRUITING

    Portland, Oregon, 97227, United States

  • Oncology Associates of Oregon, P.C.

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Texas Oncology - West Texas

    RECRUITING

    El Paso, Texas, 79902, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92037, United States

  • University of California, San Francisco (UCSF)

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 46214, United States

  • Virginia Cancer Specialists, P.C.

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • West Penn Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Women's Cancer Care Associates, LLC

    RECRUITING

    Albany, New York, 12208, United States

More trials for these conditions

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