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ZEN003694 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hunan Cancer Hospital, Changsha, ChinaBreast CancerZEN003694 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Ribociclib
1
Talazoparib Tosylate
1
SAR443216

Study Objectives

6 Primary · 22 Secondary · Reporting Duration: From screening up to 18 months

Day 30
Part 1 and Part 2: Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)
Day 15
Part 1 and Part 2: Measure the pharmacokinetic (PK) parameter: Cmax of ZEN003694 administered in combination with talazoparib
Part 1 and Part 2: Measure the pharmacokinetic (PK) parameter: Tmax of ZEN003694 administered in combination with talazoparib
Part 1 and Part 2: Measure the pharmacokinetic (PK) parameter: t1/2 of ZEN003694 administered in combination with talazoparib
Part 1: Measure the pharmacokinetic (PK) parameter: Cmin of ZEN003694 administered in combination with talazoparib
Day 28
Part 1: Measure plasma concentrations of talazoparib.
Day 28
Part 1: Measure plasma concentrations of ZEN003694 and the active metabolite ZEN003791.
Month 1
Part 1: Incidence of dose-limiting toxicities (DLT)
Day 28
Part 2, Expansion Cohorts A, B, and C: Measure plasma concentrations of ZEN003694 and the active metabolite ZEN003791.
Day 28
Part 2, Expansion Cohorts A and C: Measure plasma concentrations of talazoparib.
Month 12
Part 1 and Part 2: Evaluate duration of response (DOR)
Part 1 and Part 2: Evaluate median progression-free survival
Disease
Month 18
Expansion Cohort A: Objective response rate (ORR) by RECIST v1.1 (CR or PR)
Part 1 and Part 2: Evaluate median radiographic progression-free survival
Therapeutic procedure
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)
Part 2, Expansion Cohorts A and C: Evaluate duration of response (DOR)
Part 2, Expansion Cohorts A and C: Safety profile of ZEN003694 in combination with talazoparib.
Part 2: Clinical benefit rate (CBR)
Month 6
Part 1 and Part 2: Measure the pharmacokinetic (PK) parameter: AUC of ZEN003694 administered in combination with talazoparib
Part 1: Objective response rate (ORR) defined as a complete response (CR), partial response (PR) or stable disease (SD ≥ 4 cycles) by RECIST 1.1
Month 18
Part 1 and Part 2: Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) for Overall Duration
Part 1 and Part 2: Change from Baseline in Breast Symptoms Scale as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)
Part 2, Expansion Cohorts A and C: Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by EORTC QLQ-C30 for Overall Duration
Breast

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Ribociclib
1
Talazoparib Tosylate
1
SAR443216

Side Effects for

DE A+B 144 mg ZEN003694 + Enzalutamide
100%Dysgeusia
67%Decreased appetite
67%Visual impairment
67%Nausea
67%Weight decreased
33%Rash maculopapular
33%Small intestinal obstruction
33%Leptospirosis
33%Vision blurred
33%Thrombocytopenia
33%Fatigue
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT02711956) in the DE A+B 144 mg ZEN003694 + Enzalutamide ARM group. Side effects include: Dysgeusia with 100%, Decreased appetite with 67%, Visual impairment with 67%, Nausea with 67%, Weight decreased with 67%.

Trial Design

5 Treatment Groups

Experimental: ZEN003694 in Combination with Talazoparib
1 of 5
Expansion Cohort A - Combination Treatment in post-TROP2-ADC patients
1 of 5
Part 1 and Part 2
1 of 5
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patients
1 of 5
Expansion Cohort B - ZEN003694 Monotherapy
1 of 5

Experimental Treatment

179 Total Participants · 5 Treatment Groups

Primary Treatment: ZEN003694 · No Placebo Group · Phase 2

Experimental: ZEN003694 in Combination with TalazoparibExperimental Group · 2 Interventions: Talazoparib, ZEN003694 · Intervention Types: Drug, Drug
Expansion Cohort A - Combination Treatment in post-TROP2-ADC patientsExperimental Group · 2 Interventions: Talazoparib, ZEN003694 · Intervention Types: Drug, Drug
Part 1 and Part 2Experimental Group · 2 Interventions: Talazoparib, ZEN003694 · Intervention Types: Drug, Drug
Expansion Cohort C - Combination Treatment in TROP2-ADC-naïve patientsExperimental Group · 2 Interventions: Talazoparib, ZEN003694 · Intervention Types: Drug, Drug
Expansion Cohort B - ZEN003694 Monotherapy
Drug
Experimental Group · 1 Intervention: ZEN003694 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
ZEN003694
2016
Completed Phase 2
~120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from screening up to 18 months

Who is running the clinical trial?

PfizerIndustry Sponsor
4,352 Previous Clinical Trials
7,172,100 Total Patients Enrolled
102 Trials studying Breast Cancer
30,206 Patients Enrolled for Breast Cancer
Newsoara Biopharma Co., Ltd.Industry Sponsor
5 Previous Clinical Trials
821 Total Patients Enrolled
Zenith EpigeneticsLead Sponsor
8 Previous Clinical Trials
471 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The doctor has decided that you cannot receive hormonal treatment.
You have received no more than two chemotherapy treatments for advanced or metastatic cancer, unless the study sponsor approves it. There is no limit on the number of other types of cancer treatments you have had, such as immunotherapy, targeted therapy, or monoclonal antibodies.
You have received the TROP2-ADC treatment for advanced or metastatic cancer that cannot be surgically removed.
You have received treatment before, but the disease has continued to get worse.
You have received at least one type of treatment in the past for advanced or metastatic cancer, which may or may not have included a TROP2-ADC.

Who else is applying?

What state do they live in?
New Jersey100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Memorial Sloan Kettering Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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