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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to 18 months for reporting.

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 more

Secondary 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 more

Side effects data

From 2019 Phase 1 & 2 trial • 75 Patients • NCT02711956

75%

Visual impairment

25%

Haematuria

25%

Fatigue

25%

Weight decreased

25%

Enterococcal bacteraemia

25%

Pathological fracture

100%

80%

60%

40%

20%

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

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zenith EpigeneticsLead Sponsor

9 Previous Clinical Trials

497 Total Patients Enrolled

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,758 Total Patients Enrolled

111 Trials studying Breast Cancer

36,404 Patients Enrolled for Breast Cancer

Newsoara Biopharma Co., Ltd.Industry Sponsor

6 Previous Clinical Trials

861 Total Patients Enrolled

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03901469 — Phase 2

Breast Cancer Research Study Groups: Expansion Cohort A - Combination Treatment in post-TROP2-ADC patients, Part 1 and Part 2, Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patients, Expansion Cohort B - ZEN003694 Monotherapy

Breast Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT03901469 — Phase 2

Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03901469 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI