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A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations | Clinical Trials | Clareo Health

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A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations

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

NCT07038369•Atavistik Bio, Inc

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (8)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Florida Cancer Specialists & Research Institute - Lake Mary

Lake Mary, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

MD Anderson Cancer Center

Houston, Texas, United States

Centre Leon Berard

Lyon, France

National Cancer Centre Singapore

Singapore, Singapore

START Madrid - CIOCC

Madrid, Spain

Key Dates

Start Date

July 29, 2025

Primary Completion Date

August 31, 2028

Completion Date

January 31, 2029

Last Updated

March 17, 2026

Enrollment

134

ESTIMATED participants

Conditions

Advanced Solid TumorsBreast CancerBreast CarcinomaBreast NeoplasmsER Positive Breast CancerCervical CancersCervical NeoplasmsCervical CarcinomaTriple Negative Breast CancerGynecologic CancersGynecologic NeoplasmEndometrial CancerEndometrial NeoplasmEndometrial Carcinoma (EC)Fallopian CancerOvarian CarcinomaOvarian CancerOvarian NeoplasmsProstate CancersProstate CarcinomaSolid TumorsNeoplasmsNeoplasms by SiteBreast DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital Neoplasms

Interventions

ATV-1601

DRUG

ATV-1601 + Fulvestrant

COMBINATION_PRODUCT

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NCT05372640

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+6 more

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RECRUITINGPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations