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

Faeth Therapeutics

Status and phase

Enrolling

Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: Serabelisib

Drug: Paclitaxel

Drug: Sapanisertib

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT06463028

GOG-3111 (Other Identifier)

FTH-PIK-201

Details and patient eligibility

About

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 3 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination.
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.
Gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.
Clinically significant 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, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.
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%, fasting serum glucose > 160 mg/dL, fasting triglycerides > 300 mg/dL or receiving treatment with insulin.