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

Inclusion Criteria

• 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.

Exclusion Criteria

• Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
• Inadequate bone marrow reserve or organ function.
• Clinically significant abnormalities of glucose metabolism.
• Participants who are symptomatic or have uncontrolled brain metastases.
• Requires treatment with certain medications. Participants must meet other inclusion/exclusion criteria.