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PARP Inhibitor
ZEN003694 + Talazoparib for Triple Negative Breast Cancer (TNBC Trial)
Phase 2
Waitlist Available
Research Sponsored by Zenith Epigenetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have received TROP2-ADC therapy for unresectable locally advanced or metastatic disease (Expansion Cohort A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening up to 18 months
Awards & highlights
TNBC Trial Summary
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.
Who is the study for?
Adults with triple-negative breast cancer (TNBC) that's advanced or returned and doesn't have BRCA1/2 mutations. They must have tried chemotherapy before, can't be candidates for hormone therapy, and should not have certain blood clotting medication use or untreated brain metastases. Specific cohorts include those who've had TROP2-ADC treatment or are naive to it.Check my eligibility
What is being tested?
The trial is testing ZEN003694 alone and combined with Talazoparib in TNBC patients. It has two parts: dose escalation to find safe levels, followed by a Simon 2-Stage design to assess effectiveness. There are three groups based on prior treatments like TROP2-ADC.See study design
What are the potential side effects?
Potential side effects aren't detailed here but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, risk of infection, liver function issues, and possibly others specific to the study drugs' profiles.
TNBC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I have received TROP2-ADC therapy for my advanced or metastatic disease.
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My breast cancer is triple-negative and has spread or come back.
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I have undergone at least one chemotherapy treatment.
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My condition worsened despite previous treatments.
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I have undergone at least one round of chemotherapy.
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I've had treatment for advanced cancer but not with TROP2-ADC.
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My breast cancer is triple-negative and not responsive to hormones or HER2 treatments.
TNBC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Expansion Cohort A: Objective response rate (ORR) by RECIST v1.1 (CR or PR)
Part 1 and Part 2: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
Part 1: Incidence of dose-limiting toxicities (DLT)
+1 moreSecondary outcome measures
Part 1, Expansion Cohorts A and C: Clinical benefit rate (CBR)
Part 1, Part 2, Expansion Cohorts A and C: Evaluate median progression-free survival
Part 1, Part 2, and Expansion Cohort C: Objective response rate (ORR)
+8 moreSide effects data
From 2019 Phase 1 & 2 trial • 75 Patients • NCT0271195675%
Visual impairment
25%
Haematuria
25%
Fatigue
25%
Weight decreased
25%
Enterococcal bacteraemia
25%
Pathological fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
DE A+B 36 mg ZEN003694 + Enzalutamide
DE/DC A+B 48 mg ZEN003694 + Enzalutamide
DE A+B 60 mg ZEN003694 + Enzalutamide
DE A+B 72 mg ZEN003694 + Enzalutamide
DE/DC A+B 96 mg ZEN003694 + Enzalutamide
DE A+B 120 mg ZEN003694 + Enzalutamide
DE A+B 144 mg ZEN003694 + Enzalutamide
TNBC Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 1 and Part 2Experimental Treatment2 Interventions
ZEN003694 will be administered PO QD with Talazoparib PO QD in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
Group II: Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patientsExperimental Treatment2 Interventions
ZEN003694 will be administered PO QD with Talazoparib PO QD at the RP2D in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in China only.
Group III: Expansion Cohort B - ZEN003694 MonotherapyExperimental Treatment1 Intervention
ZEN003694 will be administered PO QD as monotherapy at the RP2D in 28-day cycles with the option to cross-over to combination treatment of ZEN003694 PO QD with Talazoparib PO QD at the time of disease progression (but no sooner than after 6 weeks of monotherapy). Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
Group IV: Expansion Cohort A - Combination Treatment in post-TROP2-ADC patientsExperimental Treatment2 Interventions
ZEN003694 will be administered PO QD with Talazoparib PO QD at the RP2D in 28-day cycles. Patients have histologically confirmed Triple Negative Breast Cancer and have no documented germline mutations of BRCA1 or BRCA2. Includes sites in the US and EU.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZEN003694
2016
Completed Phase 2
~120
Talazoparib
2021
Completed Phase 2
~2770
Find a Location
Who is running the clinical trial?
Zenith EpigeneticsLead Sponsor
9 Previous Clinical Trials
497 Total Patients Enrolled
PfizerIndustry Sponsor
4,582 Previous Clinical Trials
14,634,682 Total Patients Enrolled
113 Trials studying Breast Cancer
36,047 Patients Enrolled for Breast Cancer
Newsoara Biopharma Co., Ltd.Industry Sponsor
6 Previous Clinical Trials
861 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation to more than 25% of my bone marrow.I haven't had cancer treatment in the last 3 weeks, or 6 weeks for specific drugs.I am fully active or restricted in physically strenuous activity but can do light work.I've had 2 or fewer chemotherapy treatments for my advanced cancer.I have been treated with a PARP inhibitor before.I have a genetic mutation in BRCA1 or BRCA2.I am taking oral blood thinners that target Factor Xa or Factor IIa.I have brain metastases that are getting worse, causing symptoms, or untreated.I have a wound, ulcer, or bone fracture that is not healing.My cancer was initially ER or PR positive.My breast cancer is advanced, triple-negative, and confirmed by tests.I have received TROP2-ADC therapy for my advanced or metastatic disease.My doctor thinks hormone therapy isn't right for my condition.I have had at least one treatment for my advanced cancer.I have recovered from previous treatment side effects, except for hair loss, tiredness, or mild nerve pain.My breast cancer is triple-negative and has spread or come back.My brain metastases have been stable and untreated for at least 3 months.I have undergone at least one chemotherapy treatment.Your heart takes too long to recharge between beats.I have previously received hormone therapy for my condition.You must have a specific amount of measurable disease according to a certain set of guidelines.My condition worsened despite previous treatments.I have undergone at least one round of chemotherapy.I've had treatment for advanced cancer but not with TROP2-ADC.I have inflammatory breast cancer.My cancer got worse during platinum-based treatment.I have not had bone-targeted radionuclide therapy in the last 6 weeks.You have taken a different experimental medication that targets BET proteins, unless you were part of a specific group in a previous study.My breast cancer is triple-negative and not responsive to hormones or HER2 treatments.I am 18 years old or older.I am taking or will take medication that strongly affects certain liver enzymes.I am not using, nor plan to use strong P-gp inhibitors before or during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Cohort A - Combination Treatment in post-TROP2-ADC patients
- Group 2: Part 1 and Part 2
- Group 3: Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patients
- Group 4: Expansion Cohort B - ZEN003694 Monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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