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A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
Sponsor: Atavistik Bio, Inc
Summary
This is a Phase 1, open-label study to evaluate the safety and tolerability of ATV-1601 administered orally in adults with AKT1 E17K-mutant, advanced solid tumors and also in HR+/HER2- advanced and metastatic breast cancer, with or without fulvestrant.
Official title: A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2025-07-29
Completion Date
2029-01-31
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
ATV-1601
Drug: ATV-1601 • Oral ATV-1601
ATV-1601 + Fulvestrant
Drug: ATV-1601 * Oral ATV-1601 Drug: Fulvestrant * Intramuscular Injection
Locations (8)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Florida Cancer Specialists & Research Institute - Lake Mary
Lake Mary, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
MD Anderson Cancer Center
Houston, Texas, United States
Centre Leon Berard
Lyon, France
National Cancer Centre Singapore
Singapore, Singapore
START Madrid - CIOCC
Madrid, Spain