A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations (NCT07038369) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
United States, France, Singapore134 participantsStarted 2025-07-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Expansion: Maximum and minimum plasma concentration
Timeframe: Approximately 48 months.
2
Expansion: Time to C Max
Timeframe: Approximately 48 months
3
Expansion: Area under the concentration-time curve
Timeframe: Approximately 48 months
4
Expansion: AUC at end of dosing interval
Timeframe: Approximately 48 months
5
Expansion: AUC extrapolated to infinity
Timeframe: Approximately 48 months
6
Expansion: Half-life
Timeframe: Approximately 48 months
7
Expansion: Trough Concentrations
Timeframe: Approximately 48 months
8
Escalation & Expansion: Safety and Tolerability of monotherapy.