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

NCT07038369 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Atavistik Bio, Inc

    lead INDUSTRY

Principal Investigators

  • Study Director · Atavistik Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-29
Primary Completion
2028-08-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07038369 on ClinicalTrials.gov