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

Active Not RecruitingPhase 1

Sponsor: Atavistik Bio, Inc

Conditions: Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms, ER Positive Breast Cancer

Interventions: ATV-1601, ATV-1601 + Fulvestrant

Countries: United States, France, Singapore, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Exclusion Criteria:

1. Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
2. Inadequate bone marrow reserve or organ function.
3. Clinically significant abnormalities of glucose metabolism.
4. Participants who are symptomatic or have uncontrolled brain metastases.
5. Requires treatment with certain medications.

Participants must meet other inclusion/exclusion criteria.

Locations (8)

Los Angeles, California, United States
Lake Mary, Florida, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Houston, Texas, United States
Lyon, France
Singapore, Singapore
Madrid, Spain