NCT06463028 · Faeth Therapeutics
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
What this study is about
This is a Phase 2, conducted at multiple hospitals, where both patients and doctors know the treatment given, single-treatment group$1 study to evaluate the effectiveness and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.
View original scientific 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.
Interventions
DRUG
Sapanisertib
Oral
DRUG
Serabelisib
Oral
DRUG
Paclitaxel
Infusion
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- La Jolla, California
- San Francisco, California
- Miami Beach, Florida
- St. Petersburg, Florida
- West Palm Beach, Florida
- Brandywine, Maryland
- Maple Grove, Minnesota
- Albany, New York
- New York, New York
- Cincinnati, Ohio
- Eugene, Oregon
- Portland, Oregon
And 6 more locations — see the full list below.
Collaborators
GOG Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations