NCT06463028
Recruiting
Phase 2
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
Faeth Therapeutics18 sites in 1 country40 target enrollmentDecember 12, 2024
ConditionsEndometrial Cancer
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel
- Conditions
- Endometrial Cancer
- Sponsor
- Faeth Therapeutics
- Enrollment
- 40
- Locations
- 18
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Detailed 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.
Investigators
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.
Arms & Interventions
sapanisertib and serabelisib (PIKTOR) with paclitaxel
Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.
Intervention: Paclitaxel
sapanisertib and serabelisib (PIKTOR) with paclitaxel
Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.
Intervention: Sapanisertib
sapanisertib and serabelisib (PIKTOR) with paclitaxel
Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.
Intervention: Serabelisib
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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.)
- Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)(Up to 2 years.)
Study Sites (18)
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Related News
Faeth Therapeutics Raises $25M to Advance PIKTOR Therapy After 80% Response Rate in Endometrial Cancer- Faeth Therapeutics secured $25 million in strategic funding led by S2G Ventures, bringing total capital raised to $92 million to advance its metabolism-based cancer therapies.
- The company's PIKTOR regimen achieved an 80% overall response rate and 11-month median progression-free survival in endometrial cancer patients, significantly outperforming historical chemotherapy outcomes.
- The Gynecologic Oncology Group Foundation has initiated a Phase 2 trial based on these promising results, with full data readout expected in Q3 2026.
- Faeth's selective multi-node approach targets the PI3K/AKT/mTOR pathway while controlling tumor nutrient supply, positioning metabolism as a potential "fifth pillar" of cancer treatment.Faeth Therapeutics Advances Novel Three-Pronged Approach for Metabolism-Driven Cancers with Promising Preclinical Results- Faeth Therapeutics has published preclinical proof-of-concept data in the British Journal of Cancer supporting their multi-node PIKTOR approach, which combines dual PI3K/AKT/mTOR pathway inhibitors with an insulin-suppressing diet.
- The company's strategy targets cancer metabolism through simultaneous inhibition of multiple pathway nodes, showing tumor regression in endometrial and breast cancer models while potentially overcoming common resistance mechanisms.
- A Phase 2 trial in collaboration with The GOG Foundation is currently underway for patients with endometrial cancer, building on earlier clinical data that demonstrated an 80% objective response rate with the drug combination.