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Also known as FTH-003, MLN0128
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 the treatment of advanced or recurrent endometrial cancer. It is being evaluated in a Phase 2 clinical trial in combination with serabelisib, paclitaxel, and a substudy with an insulin-suppressing diet. It is not yet approved for any indication.
Sapanisertib targets MTOR, a kinase that regulates cell growth and proliferation. It acts as an MTOR inhibitor. By inhibiting MTOR, sapanisertib may help slow tumor growth in cancers that depend on this pathway, such as 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 for endometrial cancer.
Sapanisertib is in Phase 2 clinical development. It is being evaluated in a single active, recruiting trial for advanced or recurrent endometrial cancer. The trial has an estimated enrollment of 40 participants.
Sapanisertib is being studied in the Phase 2 trial NCT06463028, titled 'Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer.' The trial is currently recruiting female participants aged 18 years and older in the United States.