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Combination treatment for advanced endometrial cancer

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

Phase 2 Interventional Faeth Therapeutics · NCT06463028

This study is testing a new combination of medications for people with advanced endometrial cancer who haven't had success with previous treatments to see if it can help them better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years and up
SexFemale
SponsorFaeth Therapeutics Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations18 sites (La Jolla, California and 17 other locations)
Trial IDNCT06463028 on ClinicalTrials.gov

What this trial studies

This Phase 2, multicenter, open-label, single-arm study evaluates the efficacy and safety of a combination of sapanisertib and serabelisib with paclitaxel in patients with advanced or recurrent endometrial cancer. Participants must have previously failed at least one systemic therapy, including platinum-based chemotherapy and an immune checkpoint inhibitor. The study aims to assess the treatment's effectiveness in patients with specific genetic alterations in the PI3K/AKT/mTOR pathway.

Who should consider this trial

Good fit: Ideal candidates are women with advanced or recurrent endometrial cancer who have undergone prior systemic therapies and have specific genetic alterations.

Not a fit: Patients with central nervous system metastases or those who have not received prior systemic therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced endometrial cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating advanced cancers, but this specific approach is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

La Jolla, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Endometrial CancerSerabelisibSapanisertibPaclitaxelTaxolAntineoplastic AgentsPI3KAKT
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.