New drug targets rare cancer mutation in early trial
NCT ID NCT07038369
First seen Jun 24, 2026 · Last updated Aug 07, 2026 · Updated 4 times
Summary
This early-phase study tests a new oral drug, ATV-1601, in people with advanced solid tumors or certain breast cancers that have a specific AKT1 E17K mutation. The main goals are to check safety, find the right dose, and see how the drug moves through the body. About 134 adults will take part, and some may also receive a second drug called fulvestrant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ATV-1601 (a targeted drug that blocks a specific cancer-driving protein called AKT1 E17K)
- What this could lead to
- If this works, it could offer a new treatment option for people with certain advanced cancers that have a specific AKT1 mutation.
- What could go wrong
- This is a very early Phase 1 trial, so the drug may not be effective or safe in larger studies. Side effects are unknown and the mutation is rare.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic or advanced-stage solid malignant tumor or HR+/HER2- breast cancer. 2. 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. 3. Tumor must have documented specific mutation profile as outlined below based on local laboratory testing. 4. Participants with solid tumors or HR+/HER2- breast cancer with AKT1 E17K mutations. 5. Measurable disease according to RECIST v1.1 criteria. 6. Formalin-fixed paraffin-embedded tumor specimen available for submission. 7. Eastern Cooperative Oncology Group performance status of 0 or 1. Exclusion Criteria: 1. Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF. 2. Inadequate bone marrow reserve or organ function. 3. Clinically significant abnormalities of glucose metabolism. 4. Participants who are symptomatic or have uncontrolled brain metastases. 5. Requires treatment with certain medications. Participants must meet other inclusion/exclusion criteria.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Leon Berard
Lyon, 69008, France
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Florida Cancer Specialists & Research Institute - Lake Mary
Lake Mary, Florida, 32746, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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National Cancer Centre Singapore
Singapore, 168583, Singapore
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START Madrid - CIOCC
Madrid, 28050, Spain
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USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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Washington University
St Louis, Missouri, 63110, United States
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