Recruiting
Phase 2

Sapanisertib & Serabelisib

Sponsor:

Faeth Therapeutics

Code:

NCT06463028

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sapanisertib

Serabelisib

Paclitaxel

Study Details

Brief summary:

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.

Conditions

Endometrial Cancer

Study ID

NCT06463028

Start date

Dec 12, 2024

Status verified date

Dec, 2025

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: sapanisertib and serabelisib (PIKTOR) with paclitaxel

Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.

Interventions

Sapanisertib

Oral

Serabelisib

Oral

Paclitaxel

Infusion

Primary outcome measure

  • Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Medical Monitor

(708)406-9282clinicaltrials@faeththerapeutics.com

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

University of California, San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94158

Mount Sinai Comprehensive Cancer Center

Recruiting

Miami Beach, Florida, United States, 33140

Florida Cancer Specialists, North

Recruiting

St. Petersburg, Florida, United States, 33705

Florida Cancer Specialists, East

Recruiting

West Palm Beach, Florida, United States, 33401

Maryland Oncology Hematology, P.A.

Recruiting

Brandywine, Maryland, United States, 20613

Minnesota Oncology Hematology, P.A.

Recruiting

Maple Grove, Minnesota, United States, 55369

Women's Cancer Care Associates, LLC

Recruiting

Albany, New York, United States, 12208

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 46214

Oncology Associates of Oregon, P.C.

Recruiting

Eugene, Oregon, United States, 97401

Northwest Cancer Specialists, P.C.

Recruiting

Portland, Oregon, United States, 97227

Alliance Cancer Specialists, PC

Recruiting

Doylestown, Pennsylvania, United States, 18901

West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Texas Oncology - West Texas

Recruiting

El Paso, Texas, United States, 79902

Texas Oncology - Gulf Coast

Recruiting

The Woodlands, Texas, United States, 77380

Virginia Cancer Specialists, P.C.

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Faeth Therapeutics

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Serabelisib
  • Sapanisertib
  • Paclitaxel
  • Taxol
  • Antineoplastic Agents
  • PI3K
  • AKT
  • mTOR
  • Dual PI3K/mTOR inhibition
  • Genetic mutation
  • Cisplatin
  • Carboplatin
  • Genital Diseases
  • Endometrial Neoplasms
  • Advanced Endometrial Carcinoma
  • Recurrent Endometrial Carcinoma
  • Metastatic Endometrial Carcinoma
  • Endometrial Cancer
  • Endometrioid Carcinoma
  • Cancer of Endometrium
  • Cancer of the Endometrium
  • Carcinoma of Endometrium
  • Endometrial Carcinoma
  • Endometrium Cancer
  • Neoplasms, Endometrial
  • Metabolism
  • Synthetic Lethality
  • Metabolism Programming
  • PIK3CA
  • PIK3CA Mutation
  • PI3K Gene Mutation
  • PI3K/AKT/mTOR Pathway Mutation
  • AKT Gene Mutation
  • mTOR Gene Mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Faeth Therapeutics on 2025-12-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.