Clinical Trial

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

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2025-06-18; most recent amendment 2026-06-02.
Status change: Recruiting → Active, Not Recruiting 2026-02-20
Status change: Not Yet Recruiting → Recruiting 2025-08-26
Trial Details
NCT Number NCT07038369
Lead Sponsor Atavistik Bio, Inc
Conditions Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms, ER Positive Breast Cancer, Cervical Cancers, Cervical Neoplasms, Cervical Carcinoma +19 more
Enrollment 134 participants
Start Date 2025-07-29
Primary Completion 2028-08-31 (estimated)
Study Completion 2029-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-07