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

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms, ER Positive Breast Cancer, Cervical Cancers, Cervical Neoplasms, Cervical Carcinoma, Triple Negative Breast Cancer, Gynecologic Cancers, Gynecologic Neoplasm, Endometrial Cancer, Endometrial Neoplasm, Endometrial Carcinoma (EC), Fallopian Cancer, Ovarian Carcinoma, Ovarian Cancer, Ovarian Neoplasms, Prostate Cancers, Prostate Carcinoma, Solid Tumors, Neoplasms, Neoplasms by Site, Breast Diseases, Uterine Neoplasms, Genital Neoplasms, Female, Urogenital Neoplasms

In brief

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.

Key facts

Study ID

NCT07038369

Run by

Atavistik Bio, Inc

People needed

134

Starts

2025-07-29

Expected to finish

2029-01-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Florida Cancer Specialists & Research Institute - Lake Mary — Lake Mary, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Centre Leon Berard — Lyon, France
• National Cancer Centre Singapore — Singapore, Singapore
• START Madrid - CIOCC — Madrid, Spain

Full record on ClinicalTrials.gov

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