TOS-358

1 clinical trials involving this therapy/drug

This is not medical advice - consult your oncologist

Descriptions are automatically translated with AI assistance. Always verify details in the original on ClinicalTrials.gov and consult your treating physician.

RecruitingPhase IFemale onlyBreast cancerHormone receptor positive (HR+)Metastatic / advanced

A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

NCT05683418ClinicalTrials.gov ↗

The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria. The main questions it aims to answer are: 1. Phase 1a: what is the maximum tolerated dose and recommended dose for phase 2? 2. Phase 1a: how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day? 3. Phase 1b: how safe and effective is TOS-358 when given with standard of care medicines for HR+HER2- metastatic breast cancer (fulvestrant and CDK4/6i)

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