A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations

Inclusion Criteria

• •1. Histologically or cytologically confirmed metastatic or advanced-stage solid malignant tumor or HR+/HER2- breast cancer.
• •2. 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.
• •3. Tumor must have documented specific mutation profile as outlined below based on local laboratory testing.
• •4. Participants with solid tumors or HR+/HER2- breast cancer with AKT1 E17K mutations.
• •5. Measurable disease according to RECIST v1.1 criteria.
• •6. Formalin-fixed paraffin-embedded tumor specimen available for submission.
• •7. Eastern Cooperative Oncology Group performance status of 0 or 1.