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

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is 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 dose escalation and Part 2 is a Simon 2-Stage design

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zenith Epigenetics
• Collaborator: Pfizer
• Treatments: Talazoparib

Criteria

Inclusion Criteria:

1. Females or males age ≥ 18 years (at time of signing informed consent)

2. Histologically confirmed metastatic or recurrent triple-negative breast cancer (estrogen receptor (ER) ≤10%; progesterone receptor (PR) ≤10%; HER2 negative by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH)

3. Part 1: Progressed on at least 1 prior cytotoxic chemotherapy at least 21 days prior to the start of study treatment. Part 2: Progressed on no more than 3 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease (no limit on prior targeted anticancer therapies such as mechanistic target or rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF) at least 21 days prior to the start of study treatment.

4. Patient is not a candidate for endocrine based therapy or has progressed on at least 2 prior endocrine based therapies in the locally advanced or metastatic setting

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

6. Part 2 only: Measurable disease per RECIST version 1.1

Exclusion Criteria

1. Documented germline BRCA1 or BRCA2 mutations

2. Evidence of disease progression during platinum treatment either in the neoadjuvant or in the metastatic setting. For patients receiving platinum in the neoadjuvant setting, at least 12 months must have elapsed between the last dose of platinum-based treatment and enrollment.

3. Patients with inflammatory breast cancer

4. Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug.

5. Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors. For a list of strong P-gp inhibitors, refer to Section 8.4.1.

6. Prior anticancer therapy (chemotherapy, radiation, hormone therapy, immunotherapy or investigational agent) within 3 weeks from the start of study drug (except for nitrosoureas and mitomycin C within 6 weeks from start of study drug).

7. Have not progressed on prior endocrine therapy and have an ER and/or PR ≥ 1%