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A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
NCT07038369 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG ATV-1601
- COMBINATION_PRODUCT ATV-1601 + Fulvestrant
Study Locations (8)
Other
- Centre Leon Berard — Lyon
- National Cancer Centre Singapore — Singapore
- START Madrid - CIOCC — Madrid
California
- USC Norris Comprehensive Cancer Center — Los Angeles
Florida
- Florida Cancer Specialists & Research Institute - Lake Mary — Lake Mary
Massachusetts
- Massachusetts General Hospital — Boston
Missouri
- Washington University — St Louis
Texas
- MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2025-07-29 |
| Est. Completion | 2029-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07038369
The ClinicalTrials.gov registry entry for NCT07038369 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atavistik Bio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which ATV-1601 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07038369 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07038369 about?
NCT07038369 is a clinical study titled "A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations". 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.
What is the current status of trial NCT07038369?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2025-07-29. Estimated completion is 2029-01-31.
What conditions does trial NCT07038369 study?
This clinical trial studies the following conditions: Breast Cancer, Advanced Solid Tumors, Breast Carcinoma, Triple Negative Breast Cancer, Breast Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07038369?
The interventions under investigation include: ATV-1601 (DRUG), ATV-1601 + Fulvestrant (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07038369?
This trial is sponsored by Atavistik Bio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07038369 being conducted?
This trial has 8 study locations across California, Florida, Massachusetts, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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