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Sapanisertib

Phase 2

Endometrial Cancer | Small molecule | Oncology |Faeth Therapeutics, Inc. Common Stock|Last Updated: Dec 24, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Sapanisertib · 1 trial · 1 indication

Phase 2 1
NCT06463028Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial CancerEndometrial Cancer
RECRUITING40 Analytics
PHASE2RECRUITING
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
Endometrial CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR)
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 Endpoints

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.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
sapanisertib and serabelisib (PIKTOR) with paclitaxelEXPERIMENTALSubjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.

Interventions

NameTypeDescription
SapanisertibDRUGOral
SerabelisibDRUGOral
PaclitaxelDRUGInfusion
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites18

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...

Countries:United States
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Frequently asked questions about Sapanisertib

What is Sapanisertib used for in endometrial cancer?

Sapanisertib is an investigational small molecule being studied for the treatment of advanced or recurrent endometrial cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does Sapanisertib target?

Sapanisertib is a small molecule that targets mTOR, a key protein involved in cell growth and proliferation. By inhibiting mTOR, it aims to slow or stop the growth of cancer cells in endometrial cancer.

Who is developing Sapanisertib?

Sapanisertib is being developed by Sensei Biotherapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with endometrial cancer.

What phase is Sapanisertib in?

Sapanisertib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies and is still undergoing clinical trials to assess its safety and effectiveness.

What clinical trials is Sapanisertib in?

Sapanisertib is being studied in a Phase 2 clinical trial with the identifier NCT06463028. This trial is recruiting patients with advanced or recurrent endometrial cancer and is being conducted in the United States.

Is Sapanisertib the same as PIKTOR?

Sapanisertib is also known as PIKTOR. In clinical trials, it is being studied in combination with serabelisib and paclitaxel, along with a substudy involving an insulin-suppressing diet, for the treatment of endometrial cancer.