A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer
18 Years and older, Male and Female
ZEN003694-004 (primary)
NCI-2019-05264
2018-003906-26
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).
Eligibility
- Females or males age = 18 years (at time of signing informed consent)
- Parts 1 and 2 only: Histologically confirmed metastatic or recurrent or locally advanced triple-negative breast cancer (estrogen receptor (ER) =10%; progesterone receptor (PR) =10%; and HER2 negative by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) Expansion only: Histologically confirmed metastatic or recurrent, or locally advanced triple-negative breast cancer as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
- Patient is not a candidate for endocrine based therapy, based on Investigator judgement
- Have a history of progressive disease despite prior therapy
- Part 1: Have had at least 1 prior cytotoxic chemotherapy. Part 2: Have had no more than 2 prior chemotherapy-inclusive regimens for locally advanced or metastatic disease, unless approved by the Sponsor (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.) Expansion Cohort A (combination treatment in post-TROP2-ADC patients): Have received TROP2-ADC therapy for unresectable locally advanced or metastatic disease. Expansion Cohort B (ZEN003694 monotherapy): Have had at least 1 prior systemic therapy for locally advanced or metastatic disease which may or may not have included a TROP2-ADC. Expansion Cohort C (combination treatment in TROP2-ADC-naive patients): Have had at least 1 prior systemic therapy for locally advanced or metastatic disease and who have not received prior TROP2-ADC therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Part 2 and Expansion only: Measurable disease per RECIST version 1.1
Treatment Sites in Georgia
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