drugset / Trial / NCT07558733

Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer

NCT07558733

Phase 1/2 Recruiting 32 enrolled Faeth Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

Timeline

Start
2026-04-22
Primary completion
2029-05
Completion
2033-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Sapanisertib Small molecule Oral
Subject Serabelisib Small molecule Oral
Background Fulvestrant Small molecule Intramuscular