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NCT07038369 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
A Phase 1 study of Breast Cancer and Advanced Solid Tumors, sponsored by Atavistik Bio.
- Active
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
- 8
- Study locations
NCT07038369: Active Phase 1 study of Breast Cancer and Advanced Solid Tumors, sponsored by Atavistik Bio.
NCT07038369 is a Phase 1 study of Breast Cancer and Advanced Solid Tumors that is active but no longer recruiting, run by Atavistik Bio. The registered enrollment target is 134 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07038369, a Phase 1 study of Breast Cancer and Advanced Solid Tumors, is active but no longer recruiting, sponsored by Atavistik Bio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
Drug concentration in Blood.
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 |
What the registry record for NCT07038369 still lists
NCT07038369 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
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.
NCT07038369 lists 8 locations in 6 states (Other, California, Florida).
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, Triple Negative Breast Cancer, Breast Carcinoma, Breast Neoplasms.
What interventions are being tested in trial NCT07038369?
The interventions under investigation include: ATV-1601 (DRUG), ATV-1601 + Fulvestrant (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07038369?
This trial is sponsored by Atavistik Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07038369's enrollment target sits among peer trials
134 479th of 1224 higher than 742 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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