NCT03901469

A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer

A Phase 2b Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Zenith Epigenetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part open label, non-randomized, Phase 2, study of ZEN003694 in combination with Talazoparib in patients with TNBC without germline mutations of BRCA1 or BRCA2. Part 1 is a dose escalation and Part 2 is a Simon 2-Stage design. There are 3 expansion cohorts: Expansion Cohort A (combination treatment in post-TROP2-ADC patients), Expansion Cohort B (ZEN003694 monotherapy), and Expansion Cohort C (combination treatment in TROP2-ADC-naive patients).

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	ZEN003694	PO QD
DRUG	Talazoparib	PO QD

Timeline

• Start date: 2019-06-26
• Primary completion: 2024-03-07
• Completion: 2024-03-07
• First posted: 2019-04-03
• Last updated: 2025-10-07
• Results posted: 2025-10-07

Locations

19 sites across 4 countries: United States, Belgium, China, Spain

Regulatory

• FDA-regulated drug study