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.
1This trial is Phase 1 and is no longer actively recruiting — does that mean there are any results or safety findings from this study that might be relevant to my case, and could I potentially be treated with ATV-1601 through another pathway?
2Since this is a Phase 1 study focused mainly on finding the maximum tolerated dose and understanding how ATV-1601 moves through the body, what does that mean for what's actually known so far about whether it works against my specific type of cancer?
3The trial requires an AKT1 E17K mutation — has my tumor already been tested for this mutation, and if not, is that something I should pursue through molecular profiling before we discuss any next steps?
4One part of this trial combines ATV-1601 with fulvestrant — if I have ER-positive breast cancer, would a combination approach like that be something worth exploring, or would standard hormone-based therapies be a better starting point for me?
5Given that this trial covers a wide range of cancers including breast, ovarian, endometrial, and prostate, how does my specific cancer type and treatment history affect whether a drug targeting AKT1 E17K mutations might be relevant to my situation?
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.