Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 2

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

NCT ID: NCT06463028Sponsor: Faeth TherapeuticsLast updated: 2025-12-24

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.

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.

Arms & interventions

  • DrugSapanisertib

    Oral

  • DrugSerabelisib

    Oral

  • DrugPaclitaxel

    Infusion

Outcome measures

Primary

  • Objective Response Rate (ORR)

    Defined as the proportion of participants with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR).

    Time frame: Up to 2 years

Secondary

  • Progression free survival (PFS)

    Time frame: Up to 5 years.

  • Progression free survival (PFS) at 6 months

    Time frame: Up to 5 years.

  • Overall survival (OS)

    Time frame: Up to 5 years.

  • Clinical benefit rate (CBR)

    Time frame: Up to 5 years.

  • Duration of response (DoR)

    Time frame: 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.

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (18)

UC San Diego Moores Cancer Center

La Jolla, California, 92037

Recruiting

University of California, San Francisco (UCSF)

San Francisco, California, 94158

Recruiting

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

Recruiting

Florida Cancer Specialists, North

St. Petersburg, Florida, 33705

Recruiting

Florida Cancer Specialists, East

West Palm Beach, Florida, 33401

Recruiting

Maryland Oncology Hematology, P.A.

Brandywine, Maryland, 20613

Recruiting

Minnesota Oncology Hematology, P.A.

Maple Grove, Minnesota, 55369

Recruiting

Women's Cancer Care Associates, LLC

Albany, New York, 12208

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

University of Cincinnati Medical Center

Cincinnati, Ohio, 46214

Recruiting

Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401

Recruiting

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97227

Recruiting

Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, 18901

Recruiting

West Penn Hospital

Pittsburgh, Pennsylvania, 15224

Recruiting

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Recruiting

Texas Oncology - West Texas

El Paso, Texas, 79902

Recruiting

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380

Recruiting

Virginia Cancer Specialists, P.C.

Fairfax, Virginia, 22031

Recruiting

References

  • Starks DC, Rojas-Espaillat L, Meissner T, Williams CB. Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors. Gynecol Oncol. 2022 Sep;166(3):403-409. doi: 10.1016/j.ygyno.2022.07.005. Epub 2022 Jul 15.(PubMed)