This trial is testing a new drug, ZEN003694, in combination with an existing drug, Talazoparib, in patients with Triple-Negative Breast Cancer (TNBC) who do not have BRCA1 or BRCA2 mutations. The trial has two parts: a dose escalation part to find the best dose of the new drug, and a Simon 2-Stage design part to test how well the combination works. There are three expansion cohorts testing different aspects of the combination.
- Breast Cancer
6 Primary · 22 Secondary · Reporting Duration: From screening up to 18 months
Side Effects for
5 Treatment Groups
Experimental: ZEN003694 in Combination with Talazoparib
1 of 5
Expansion Cohort A - Combination Treatment in post-TROP2-ADC patients
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Part 1 and Part 2
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Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patients
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Expansion Cohort B - ZEN003694 Monotherapy
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179 Total Participants · 5 Treatment Groups
Primary Treatment: ZEN003694 · No Placebo Group · Phase 2
Who is running the clinical trial?
Age 18+ · All Participants · 12 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
How old are they?
|18 - 65||100.0%|
What site did they apply to?
|Memorial Sloan Kettering Cancer Center||100.0%|
What portion of applicants met pre-screening criteria?
- Kharenko, Olesya A., Reena G. Patel, Cyrus Calosing, and Edward H. van der Horst. 2021. “Combination of ZEN-3694 with CDK4/6 Inhibitors Reverses Acquired Resistance to CDK4/6 Inhibitors in Er-positive Breast Cancer”. Cancer Gene Therapy. Springer Science and Business Media LLC. doi:10.1038/s41417-021-00375-9.
- 2019. "A Study of ZEN003694 and Talazoparib in Patients With Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03901469.
Frequently Asked Questions
Are there any ongoing research projects on ZEN003694?
"ZEN003694 was first trialled a decade ago at City of Hope. So far, there have been 25 clinical trials completed with 60 more active studies underway. A large number of these are based in New York City." - Anonymous Online Contributor
Are people still being recruited for this test program?
"Yes, this study is still open and looking for participants. The listing on clinicaltrials.gov shows that it was first posted on June 26th, 2019 and updated as recently as July 13th, 2020." - Anonymous Online Contributor
Is this trial widely available to Canadian patients?
"Currently, this study is being conducted at Memorial Sloan Kettering Cancer Center in New York, University of Kansas Cancer Center in Westwood, and Tennessee Oncology (Sarah Cannon) in Nashville. There are also 6 other sites running this trial." - Anonymous Online Contributor
Does ZEN003694 have the go-ahead from the FDA?
"ZEN003694 falls into Phase 2 of clinical trials, which means that while there is data supporting safety, there are no studies yet proving efficacy. Our team at Power rates it as a 2." - Anonymous Online Contributor
How many people are being given the chance to participate in this experiment?
"This clinical trial needs 179 participants that meet the specified inclusion criteria. Patients can choose to participate in this study at Memorial Sloan Kettering Cancer Center or University of Kansas Cancer Center." - Anonymous Online Contributor