Trials / Recruiting
RecruitingNCT05683418
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With HR+ Breast Cancer and Other Select Solid Tumors
A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 241 (estimated)
- Sponsor
- Totus Medicines · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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?
Detailed description
This study will be conducted in two parts: a dose finding portion to determine the maximum tolerated dose and recommended phase 2 dose (RP2D) of TOS-358 administered orally on once a day (QD) and twice daily (BID) schedules, and a dose expansion portion to evaluate safety and tolerability in tumor-specific cohorts administered TOS-358 at the recommended phase 2 dose and schedule. Adult subjects with histologically confirmed diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer, squamous cell carcinoma of the head and neck, cancer of the bladder, or endometrial cancer with known PIK3CA mutations or amplifications and who meet all of the eligibility criteria will be enrolled in the study. In the dose finding portion of the study, TOS-358 will be evaluated as a single-agent at multiple dose levels administered orally until disease progression, unacceptable toxicity, or until meeting any other reason for discontinuation as specified in the protocol.
Conditions
- Squamous Cell Carcinoma of Head and Neck
- Endometrial Cancer
- HR+/HER2-negative Breast Cancer
- Bladder Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TOS-358 | Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor |
Timeline
- Start date
- 2023-02-15
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2023-01-13
- Last updated
- 2025-07-22
Locations
18 sites across 2 countries: United States, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05683418. Inclusion in this directory is not an endorsement.