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

Launched by ATAVISTIK BIO, INC · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new oral medicine called ATV-1601 to see if it is safe and well-tolerated in adults who have advanced cancers with a specific genetic change called the AKT1 E17K mutation. This includes various types of cancers such as breast cancer, ovarian cancer, prostate cancer, and other solid tumors that have spread or come back after standard treatments. The study is currently not enrolling participants yet.

People who might be eligible for this trial are adults with advanced or metastatic solid tumors or a certain type of breast cancer (hormone receptor positive and HER2 negative) that have this specific AKT1 mutation. They should have tried standard treatments that either did not work or caused intolerable side effects, and their cancer needs to be measurable by scans. Participants should be in generally good health aside from their cancer and not have certain other genetic mutations or uncontrolled brain tumors. If eligible, participants will take ATV-1601 by mouth and be closely monitored to learn about the drug’s safety and how well it is tolerated. This study is an early step in research, so the main goal is to understand the drug’s effects rather than to prove it works yet.

Gender

ALL

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.