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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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

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.

Country

City, postcode or hospital

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

Other trials in United States

France1 site

Centre Leon Berard
Lyon, 69008

Other trials in France

Singapore1 site

National Cancer Centre Singapore
Singapore, 168583

Other trials in Singapore

Spain1 site

START Madrid - CIOCC
Madrid, 28050

Other trials in Spain

About this study

Official title: A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors

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 groups in NCT07038369
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.

29 Jul 202531 Jan 2029

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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