Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer

December 22, 2025 updated by: Faeth Therapeutics

An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus an Insulin-Suppressing Diet, in Patients With Advanced or Recurrent Endometrial Cancer

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer who have failed prior systemic therapies, including a platinum-based therapy and an immune checkpoint inhibitor, either separately or together.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Moores Cancer Center
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California, San Francisco (UCSF)
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists, North
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists, East
    • Maryland
      • Brandywine, Maryland, United States, 20613
        • Recruiting
        • Maryland Oncology Hematology, P.A.
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Women's Cancer Care Associates, LLC
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 46214
        • Recruiting
        • University of Cincinnati Medical Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Oncology Associates of Oregon, P.C.
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Northwest Cancer Specialists, P.C.
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Recruiting
        • Alliance Cancer Specialists, PC
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
    • Texas
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Texas Oncology - West Texas
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology - Gulf Coast
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sapanisertib and serabelisib (PIKTOR) with paclitaxel
Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.
Drug: Sapanisertib
Oral
Other Names:
  • MLN0128
  • FTH-003
Drug: Serabelisib
Oral
Other Names:
  • MLN1117
  • FTH-001
Drug: Paclitaxel
Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 2 years
Defined as the proportion of participants with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR).
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Up to 5 years.
Defined as the time from first dose until the date of disease progression or death.
Up to 5 years.
Progression free survival (PFS) at 6 months
Time Frame: Up to 5 years.
Defined as PFS rate at 6 months.
Up to 5 years.
Overall survival (OS)
Time Frame: Up to 5 years.
Defined as the time from first dose to death.
Up to 5 years.
Clinical benefit rate (CBR)
Time Frame: Up to 5 years.
Defined as the percentage of participants who achieve complete response (CR), partial response (PR), or have stable disease (SD) of at least 16 or 24 weeks.
Up to 5 years.
Duration of response (DoR)
Time Frame: Up to 5 years.
Defined for participants with confirmed CR or PR as the time from response until date of documented disease progression or death.
Up to 5 years.
Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)
Time Frame: Up to 2 years.
Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).
Up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faeth Therapeutics

Collaborators

GOG Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTH-PIK-201
  • GOG-3111 (Other Identifier: GOG Foundation/Partners)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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