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ACTIVE NOT RECRUITING
NCT07038369
PHASE1

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2025-07-29

Completion Date

2029-01-31

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DRUG

ATV-1601

Drug: ATV-1601 • Oral ATV-1601

COMBINATION_PRODUCT

ATV-1601 + Fulvestrant

Drug: ATV-1601 * Oral ATV-1601 Drug: Fulvestrant * Intramuscular Injection

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