Advanced Solid TumorsPhase 1NCT07038369
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
A Phase 1 study testing ATV-1601 and ATV-1601 + Fulvestrant in people with Advanced Solid Tumors and Breast Cancer, run by Atavistik Bio, Inc at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Breast Cancer, Breast Carcinoma
- What is being tested?
- ATV-1601 and ATV-1601 + Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 29 Jul 2025to 31 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Who cannot join
- Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
- Inadequate bone marrow reserve or organ function.
- Clinically significant abnormalities of glucose metabolism.
- Participants who are symptomatic or have uncontrolled brain metastases.
- Requires treatment with certain medications.
- Participants must meet other inclusion/exclusion criteria.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
MD Anderson Cancer Center
Houston, Texas, 77030
Florida Cancer Specialists & Research Institute - Lake Mary
Lake Mary, Florida, 32746
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors
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.
Read the detailed description
This is a first-in-human, open-label, multicenter, Phase 1a/1b dose escalation dose finding, and dose expansion study to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic solid tumors with the AKT1 E17K mutation, and in combination with fulvestrant in participants with breast cancer that has the AKT1 E17K mutation. This study has a dose escalation and expansion phase with ATV-1601, and an escalation and expansion phase in combination with Fulvestrant.
- Conditions
- Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms, ER Positive Breast Cancer, Cervical Cancers
- Being tested
- ATV-1601, ATV-1601 + Fulvestrant
- Keywords
- AKT mutation, Mutant AKT, AKT1 mutation, AKT mutant, Gynecologic carcinoma, Fallopian Carcinoma, Fallopian Neoplasm, HR positive breast, AKT Gene Mutation, AKT1 E17K
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Genital Neoplasms, Female, Endometrial Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATV-1601Drug
Drug: ATV-1601
- Oral ATV-1601
ATV-1601 + FulvestrantCombination product
Drug: ATV-1601
- Oral ATV-1601 Drug: Fulvestrant
- Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental/Part 1a: ATV-1601 | Experimental | ATV-1601 Receives: Drug: ATV-1601 |
| Experimental/Part 1b: ATV-1601 + Fulvestrant | Experimental | ATV-1601 + Fulvestrant Receives: Combination Product: ATV-1601 + Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expansion: Maximum and minimum plasma concentration
Drug concentration in Blood.
Measured: Approximately 48 months.
Expansion: Time to C Max
Drug concentration in Blood
Measured: Approximately 48 months
Expansion: Area under the concentration-time curve
Drug concentration in Blood
Measured: Approximately 48 months
Expansion: AUC at end of dosing interval
Drug concentration in Blood
Measured: Approximately 48 months
Expansion: AUC extrapolated to infinity
Drug concentration in Blood
Measured: Approximately 48 months
Expansion: Half-life
Drug concentration in Blood
Measured: Approximately 48 months
Expansion: Trough Concentrations
Drug concentration in Blood
Measured: Approximately 48 months
Escalation & Expansion: Safety and Tolerability of monotherapy.
Number of participants with Treatment Emergent Adverse Events (TEAEs). Safety will be assessed by monitoring adverse events, laboratory tests and ECG results.
Measured: Approximately 48 months.
Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 in monotherapy.
Number of patients with dose-limiting toxicities.
Measured: Approximately 48 months.
Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 combination with fulvestrant.
Number of patients with dose-limiting toxicities.
Measured: Approximately 48 months.
Secondary outcomes (11)
Escalation: Maximum and minimum plasma concentration
Drug concentration in Blood.
Measured: Approximately 48 months.
Escalation: Time to C max
Drug concentration in Blood
Measured: Approximately 48 months
Escalation: Area under the concentration-time curve
Drug concentration in Blood
Measured: Approximately 48 months
Escalation: AUC at end of dosing interval
Drug concentration in Blood
Measured: Approximately 48 months
Escalation: AUC extrapolated to infinity
Drug concentration in Blood
Measured: Approximately 48 months
Escalation: Half-life
Drug concentration in Blood
Measured: Approximately 48 months
Escalation: Trough Concentrations
Drug concentration in Blood
Measured: Approximately 48 months
Escalation & Expansion: Objective response rate
Tumor measurements by RECIST 1.1
Measured: Approximately 48 months
Escalation & Expansion: Duration of Response
Tumor measurements by RECIST 1.1
Measured: Approximately 48 months
Escalation & Expansion: Clinical Benefit Rate
Tumor measurements by RECIST 1.1
Measured: Approximately 48 months
Expansion: Progression Free Survival
Tumor measurements by RECIST 1.1
Measured: Approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start29 Jul 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atavistik Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Atavistik Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038369
- Sponsor's protocol ID
- ATV-1601-101
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07038369
- Acronym / sponsor ID
- ATV-1601-101
- Conditions
- Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms, ER Positive Breast Cancer, Cervical Cancers
- Keywords
- AKT mutation, Mutant AKT, AKT1 mutation, AKT mutant, Gynecologic carcinoma, Fallopian Carcinoma, Fallopian Neoplasm, HR positive breast
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Atavistik Bio, IncIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a first-in-human, open-label, multicenter, Phase 1a/1b dose escalation dose finding, and dose expansion study to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic solid tumors with the AKT1 E17K mutation, and in combination with fulvestrant in participants with breast cancer that has the AKT1 E17K mutation. This study has a dose escalation and expansion phase with ATV-1601, and an escalation and expansion phase in combination with Fulvestrant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental/Part 1a: ATV-1601 | Experimental | Drug: ATV-1601ATV-1601 |
| Experimental/Part 1b: ATV-1601 + Fulvestrant | Experimental | Combination Product: ATV-1601 + FulvestrantATV-1601 + Fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
- Inadequate bone marrow reserve or organ function.
- Clinically significant abnormalities of glucose metabolism.
- Participants who are symptomatic or have uncontrolled brain metastases.
- Requires treatment with certain medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATV-1601Drug: ATV-1601 • Oral ATV-1601 | Drug | Experimental/Part 1a: ATV-1601 |
| ATV-1601 + FulvestrantDrug: ATV-1601 * Oral ATV-1601 Drug: Fulvestrant * Intramuscular Injection | Combination product | Experimental/Part 1b: ATV-1601 + Fulvestrant |
Primary outcome
Expansion: Maximum and minimum plasma concentration
Time frame: Approximately 48 months.
Drug concentration in Blood.
Expansion: Time to C Max
Time frame: Approximately 48 months
Drug concentration in Blood
Expansion: Area under the concentration-time curve
Time frame: Approximately 48 months
Drug concentration in Blood
Expansion: AUC at end of dosing interval
Time frame: Approximately 48 months
Drug concentration in Blood
Expansion: AUC extrapolated to infinity
Time frame: Approximately 48 months
Drug concentration in Blood
Expansion: Half-life
Time frame: Approximately 48 months
Drug concentration in Blood
Expansion: Trough Concentrations
Time frame: Approximately 48 months
Drug concentration in Blood
Escalation & Expansion: Safety and Tolerability of monotherapy.
Time frame: Approximately 48 months.
Number of participants with Treatment Emergent Adverse Events (TEAEs). Safety will be assessed by monitoring adverse events, laboratory tests and ECG results.
Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 in monotherapy.
Time frame: Approximately 48 months.
Number of patients with dose-limiting toxicities.
Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 combination with fulvestrant.
Time frame: Approximately 48 months.
Number of patients with dose-limiting toxicities.
11 secondary outcomes
Escalation: Maximum and minimum plasma concentration
Time frame: Approximately 48 months.
Escalation: Time to C max
Time frame: Approximately 48 months
Escalation: Area under the concentration-time curve
Time frame: Approximately 48 months
Escalation: AUC at end of dosing interval
Time frame: Approximately 48 months
Escalation: AUC extrapolated to infinity
Time frame: Approximately 48 months
Escalation: Half-life
Time frame: Approximately 48 months
Escalation: Trough Concentrations
Time frame: Approximately 48 months
Escalation & Expansion: Objective response rate
Time frame: Approximately 48 months
Escalation & Expansion: Duration of Response
Time frame: Approximately 48 months
Escalation & Expansion: Clinical Benefit Rate
Time frame: Approximately 48 months
Expansion: Progression Free Survival
Time frame: Approximately 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Atavistik Bio
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATV-1601 and ATV-1601 + Fulvestrant in people with Advanced Solid Tumors and Breast Cancer, run by Atavistik Bio, Inc at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, France, Singapore, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expansion: Maximum and minimum plasma concentration (time frame: Approximately 48 months.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.