A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors
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.
• Histologically or cytologically confirmed metastatic or advanced-stage solid malignant tumor or HR+/HER2- breast cancer.
• Have progressed on, were intolerant to, or experienced disease recurrence after standard therapy and have no available effective or tolerable treatment options to derive clinically meaningful benefit.
• Tumor must have documented specific mutation profile as outlined below based on local laboratory testing.
• Participants with solid tumors or HR+/HER2- breast cancer with AKT1 E17K mutations.
• Measurable disease according to RECIST v1.1 criteria.
• Formalin-fixed paraffin-embedded tumor specimen available for submission.
• Eastern Cooperative Oncology Group performance status of 0 or 1.