A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Totus Medicines
- Study ID
- NCT05683418
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- HR+/HER2-negative Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TOS-358 — DRUGCovalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor
- Fulvestrant — DRUGIntramuscular SERD at standard doses
- Palbociclib — DRUGCDK4/6 inhibitor at standard doses
- Ribociclib — DRUGCDK4/6 inhibitor at standard doses
Study Details
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)
Key Dates
- First listed
- Jan 13, 2023
- Start date
- Feb 15, 2023
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 241 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TOS-358 + fulvestrantTOS-358 + fulvestrant at standard dosing
- Experimental: TOS-358 + fulvestrant + CDK4/6iTOS-358 + fulvestrant + CDK4/6i
- Experimental: TOS-358PIK3CA covalent inhibitor
Primary Outcome Measure
Determine the rate of dose-limiting toxicities (DLTs) [ Time Frame: First 21 days of treatment ]
Central Contacts
- Clinical TrialsPlease e-mail
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | William Gradishar, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Gary Barahona Gerburg Wulf, MD (PRINCIPAL_INVESTIGATOR) |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Abigail Goldberg Antonio Giordano, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | Eidan Gutierrez Liawaty Ho, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19106 | Study Coordinator Mark Diamond, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | Erika Hamilton, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | Jordan Berlin, MD (PRINCIPAL_INVESTIGATOR) Vandana Abramson, MD (SUB_INVESTIGATOR) |
| Texas Oncology - Flower Mound | Flower Mound | Texas | 75028 | Vibha T Thomas, MD (PRINCIPAL_INVESTIGATOR) |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 |
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