Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sapanisertib · 1 trial · 1 indication
Defined as the proportion of participants with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR).
| Arm | Type | Description |
|---|---|---|
| sapanisertib and serabelisib (PIKTOR) with paclitaxel | EXPERIMENTAL | Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously. |
| Name | Type | Description |
|---|---|---|
| Sapanisertib | DRUG | Oral |
| Serabelisib | DRUG | Oral |
| Paclitaxel | DRUG | Infusion |
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 t...
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Sapanisertib is an investigational small molecule being studied for advanced or recurrent endometrial cancer. It is being evaluated in a Phase 2 trial in combination with serabelisib, paclitaxel, and a substudy with an insulin-suppressing diet. The trial is currently recruiting female patients aged 18 years and older in the United States.
Sapanisertib targets MTOR, a kinase involved in cell growth and proliferation. It acts as an MTOR inhibitor. By inhibiting MTOR, sapanisertib may interfere with signaling pathways that drive tumor growth, which is the rationale for its study in endometrial cancer.
Sapanisertib is being developed by Faeth Therapeutics, Inc., which trades under the ticker FTH. The company is sponsoring the clinical development of sapanisertib in endometrial cancer.
Sapanisertib is in Phase 2 clinical development. It is not approved by the FDA and remains investigational. The ongoing Phase 2 trial is evaluating the drug in patients with advanced or recurrent endometrial cancer.
Sapanisertib is being studied in one active clinical trial, NCT06463028. This Phase 2 trial is titled "Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer." It is currently recruiting participants and has an estimated enrollment of 40 patients.