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

NCT03901469 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-10-07

Study results available
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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

Interventions

DRUG

ZEN003694

PO QD

DRUG

Talazoparib

PO QD

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Newsoara Biopharma Co., Ltd.

    collaborator INDUSTRY

  • Zenith Epigenetics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2024-03-07
Completion
2024-03-07
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • China
  • Spain

Study Locations

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Entities

Diseases
Companies

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 NCT03901469 on ClinicalTrials.gov