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A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT07038369.
