NCT07038369

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Atavistik Bio, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• ER Positive Breast Cancer
• Cervical Cancers
• Cervical Neoplasms
• Cervical Carcinoma
• Triple Negative Breast Cancer
• Gynecologic Cancers
• Gynecologic Neoplasm
• Endometrial Cancer
• Endometrial Neoplasm
• Endometrial Carcinoma (EC)
• Fallopian Cancer
• Ovarian Carcinoma
• Ovarian Cancer
• Ovarian Neoplasms
• Prostate Cancers
• Prostate Carcinoma
• Solid Tumors
• Neoplasms
• Neoplasms by Site
• Breast Diseases
• Uterine Neoplasms
• Genital Neoplasms, Female
• Urogenital Neoplasms

Interventions

Type	Name	Description
DRUG	ATV-1601	Drug: ATV-1601 • Oral ATV-1601
COMBINATION_PRODUCT	ATV-1601 + Fulvestrant	Drug: ATV-1601 * Oral ATV-1601 Drug: Fulvestrant * Intramuscular Injection

Timeline

• Start date: 2025-07-29
• Primary completion: 2028-08-31
• Completion: 2029-01-31
• First posted: 2025-06-26
• Last updated: 2026-03-17

Locations

8 sites across 4 countries: United States, France, Singapore, Spain

Regulatory

• FDA-regulated drug study