A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
Recruiting
Phase 1
Interventional Study
HR+/HER2-negative Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 241 (estimated)
- Sponsor
- Totus Medicines · Industry
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About This Trial
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 diffe…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria
* Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer
* Up to 3 prior lines of therapy for metastatic disease
* Willing and able to provide written informed consent for this study
* Adults ≥ 18 years old at time of consent
* Known PIK3CA mutations or amplifica…
Contacts