OncoMatch/Clinical Trials/NCT05683418
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With HR+ Breast Cancer and Other Select Solid Tumors
Is NCT05683418 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TOS-358 for squamous cell carcinoma of head and neck.
Treatment: TOS-358 — The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select solid tumors who meet study enrollment criteria. The main questions it aims to answer are: 1. what is the maximum tolerated dose and recommended dose for phase 2? 2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day?
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Endometrial Cancer
Breast Carcinoma
Urothelial Carcinoma
Biomarker criteria
Required: PIK3CA amplification
Required: PIK3CA mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PI3K inhibitor
Exception: breast cancer patients
For non-breast cancer: prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
Cannot have received: AKT inhibitor
Exception: breast cancer patients
For non-breast cancer: prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
Cannot have received: mTOR inhibitor
Exception: breast cancer patients
For non-breast cancer: prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
Cannot have received: PI3K-AKT-mTOR pathway inhibitor
Exception: breast cancer patients
For non-breast cancer: prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
Lab requirements
Blood counts
adequate bone marrow function within 14 days prior to first dose of investigational product
Kidney function
adequate kidney function within 14 days prior to first dose of investigational product
Liver function
adequate liver function within 14 days prior to first dose of investigational product
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Southern California, Norris Comprehensive Cancer Center · Los Angeles, California
- Northwestern Memorial Hospital · Chicago, Illinois
- Massachusetts General Hospital Cancer Center · Boston, Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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