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

NCT06463028 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: FTH-PIK-201GOG-3111
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 18

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

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 2 years

Secondary Outcomes (6)

• Progression free survival (PFS)

  Up to 5 years.

• Progression free survival (PFS) at 6 months

  Up to 5 years.

• Overall survival (OS)

  Up to 5 years.

• Clinical benefit rate (CBR)

  Up to 5 years.

• Duration of response (DoR)

  Up to 5 years.

Study Arms (1)

sapanisertib and serabelisib (PIKTOR) with paclitaxel

EXPERIMENTAL

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

Drug: Sapanisertib; Drug: Serabelisib; Drug: Paclitaxel

Interventions

Sapanisertib DRUG

Oral

Also known as: FTH-003, MLN0128

sapanisertib and serabelisib (PIKTOR) with paclitaxel

Serabelisib DRUG

Oral

Also known as: FTH-001, MLN1117

sapanisertib and serabelisib (PIKTOR) with paclitaxel

Paclitaxel DRUG

Infusion

sapanisertib and serabelisib (PIKTOR) with paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faeth Therapeutics: lead
• GOG Foundation: collaborator

Study Sites (18)

UC San Diego Moores Cancer Center

La Jolla, California, 92037, United States

RECRUITING

University of California, San Francisco (UCSF)

San Francisco, California, 94158, United States

RECRUITING

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

RECRUITING

Florida Cancer Specialists, North

St. Petersburg, Florida, 33705, United States

RECRUITING

Florida Cancer Specialists, East

West Palm Beach, Florida, 33401, United States

RECRUITING

Maryland Oncology Hematology, P.A.

Brandywine, Maryland, 20613, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Maple Grove, Minnesota, 55369, United States

RECRUITING

Women's Cancer Care Associates, LLC

Albany, New York, 12208, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 46214, United States

RECRUITING

Oncology Associates of Oregon, P.C.

Eugene, Oregon, 97401, United States

RECRUITING

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97227, United States

RECRUITING

Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, 18901, United States

RECRUITING

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Texas Oncology - West Texas

El Paso, Texas, 79902, United States

RECRUITING

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380, United States

RECRUITING

Virginia Cancer Specialists, P.C.

Fairfax, Virginia, 22031, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35843739 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Endometrial Neoplasms; Genital Diseases; Carcinoma, Endometrioid; Hereditary Sensory and Autonomic Neuropathies

Interventions

sapanisertib; serabelisib; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Medical Monitor

CONTACT

(708)406-9282; clinicaltrials@faeththerapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)