NCT06463028 Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
| NCT ID | NCT06463028 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Faeth Therapeutics |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-12-12 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06463028 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06463028 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06463028 currently recruiting?
Yes, NCT06463028 is actively recruiting participants. Contact the research team at clinicaltrials@faeththerapeutics.com for enrollment information.
Where is the NCT06463028 trial being conducted?
This trial is being conducted at La Jolla, United States, San Francisco, United States, Miami Beach, United States, St. Petersburg, United States and 11 additional locations.
Who is sponsoring the NCT06463028 clinical trial?
NCT06463028 is sponsored by Faeth Therapeutics. The trial plans to enroll 40 participants.
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