NCT07038369Active, not recruitingPhase 1
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 18 Jun 2025
- Start date
- 29 Jul 2025
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Atavistik Bio, Inc
- Diseases
- Prostate cancer, Triple-negative breast cancer, Endometrial cancer, Cervical cancer, Ovarian cancer
- NCT number
- NCT07038369
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 134
- From 29 Jul 2025 to the primary completion date, 31 Aug 2028
- 8 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
- Requires treatment with certain medications.
- Participants must meet other inclusion/exclusion criteria.
Lab values
- Clinically significant abnormalities of glucose metabolism.
Other
- Inadequate bone marrow reserve or organ function.
- Participants who are symptomatic or have uncontrolled brain metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| START Madrid - CIOCC Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| National Cancer Centre Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Florida Cancer Specialists & Research Institute - Lake Mary Coordinator of this site? Confirm its status | Lake Mary | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.