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PARP Inhibitor
ZEN-3694 + Talazoparib for Cancer
Phase 2
Recruiting
Led By Timothy A Yap
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a tumor lesion that can be biopsied with 'low' or 'minimal' risk and at least one measurable disease site, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Age >= 18 years
Must not have
Patients with cerebrovascular accident (CVA), myocardial infarction, or unstable angina within 6 months prior to the first dose of ZEN003694 (ZEN-3694) or talazoparib
Patients who have previously received ZEN003694 (ZEN-3694) or who have been treated with an investigational BET inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if combining ZEN-3694 and talazoparib can shrink advanced tumors that don't respond to standard treatments. ZEN-3694 blocks proteins that help tumors grow, and talazoparib stops cancer cells from fixing their damaged DNA, causing them to die. The study also looks at how patients' genes affect their response to this treatment. Talazoparib is a potent PARP inhibitor that has shown significant efficacy in treating advanced BRCA1 and BRCA2 mutated breast cancer.
Who is the study for?
Adults with advanced solid tumors that are metastatic or unresectable, where standard treatments have failed. Participants must meet specific health criteria like adequate blood cell counts and organ function, agree to use contraception, and not be pregnant or breastfeeding. Some cohorts require genetic mutations in cancer-related genes (e.g., BRCA1/2 or KRAS). Prior therapies are allowed but with certain time frames for recovery.
What is being tested?
The trial is testing the combination of ZEN-3694, a BET protein inhibitor which may stop tumor growth by targeting overproduced proteins in cancer cells, and Talazoparib, a PARP enzyme inhibitor that prevents cancer cells from repairing their DNA. The study also examines how patients' genetics affect their response to this treatment.
What are the potential side effects?
Potential side effects include issues related to the body's ability to repair DNA damage which could lead to increased risk of developing new cancers or worsening existing ones. Other common drug-related side effects such as fatigue, nausea, allergic reactions might occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be safely biopsied and at least one tumor that can be measured.
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I am 18 years old or older.
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I have chronic hepatitis B but my viral load is undetectable with treatment.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had a stroke, heart attack, or severe chest pain in the last 6 months.
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I have not been treated with ZEN-3694 or any experimental BET inhibitors.
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I am not taking any blood thinners except for low molecular weight heparin.
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I have a digestive issue that affects how my body absorbs medication.
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I cannot or will not take pills.
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I am not taking any strong CYP3A4 inhibitors or inducers, or can stop them 7 days before starting ZEN-3694.
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I do not have any unmanaged ongoing illnesses.
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More than a quarter of my bone marrow has been exposed to radiation.
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I do not have an active infection needing IV antibiotics or any severe illness requiring hospitalization.
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I am not pregnant or breastfeeding.
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I am allergic to medications similar to ZEN-3694 or talazoparib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Clinical benefit rate (CBR)
Duration of response
Incidence of adverse events
+2 moreOther study objectives
Analysis of formalin-fixed paraffin-embedded and blood and blood samples
Assess emergent resistant mutations
Correlate baseline mutations with treatment response
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ZEN-3694, talazoparib)Experimental Treatment5 Interventions
Patients receive ZEN-3694 PO QD and talazoparib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo diagnostic imaging throughout the study and undergo blood sample collection and tumor biopsy while on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1150
Biospecimen Collection
2004
Completed Phase 3
~2030
Talazoparib
2021
Completed Phase 2
~2810
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
BET inhibitors, such as ZEN003694, work by targeting the bromodomain and extra-terminal (BET) family of proteins, which play a crucial role in regulating gene expression that promotes tumor growth. By inhibiting these proteins, BET inhibitors can prevent the proliferation of cancer cells.
PARP inhibitors, like Talazoparib, block the PARP enzyme involved in DNA repair. This inhibition prevents cancer cells from repairing their damaged DNA, leading to cell death.
These mechanisms are particularly important for solid tumor patients because they target the fundamental processes that allow cancer cells to grow and survive, offering a targeted approach that can potentially improve treatment outcomes and reduce side effects compared to traditional chemotherapy.
Development of the PARP inhibitor talazoparib for the treatment of advanced <i>BRCA1</i> and <i>BRCA2</i> mutated breast cancer.
Development of the PARP inhibitor talazoparib for the treatment of advanced <i>BRCA1</i> and <i>BRCA2</i> mutated breast cancer.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,937 Previous Clinical Trials
41,019,386 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
9 Previous Clinical Trials
445 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor that can be safely biopsied and at least one tumor that can be measured.I agree to use contraception during and for 4 months after the study.I have not been treated with ZEN-3694 or any experimental BET inhibitors.My cancer is in an area that was previously treated with radiation.I have a BRCA mutation and my last treatment was with PARP inhibitors.I haven't had bone-targeted radionuclide therapy in the last 6 weeks.I am 18 years old or older.I haven't had a stroke, heart attack, or severe chest pain in the last 6 months.I do not have any unmanaged ongoing illnesses.My advanced cancer has a KRAS mutation and I've had KRAS-targeted treatment if it's G12C.I agree to use birth control or abstain from sex during and for 7 months after the study.My heart is healthy enough for the trial, as per the New York Heart Association standards.I haven't had major surgery, except for diagnosis, dental work, or stenting, in the last 4 weeks.My kidney function is good enough for the trial, with a GFR of at least 60 mL/min/1.73 m^2 or safely lower.I am not taking any blood thinners except for low molecular weight heparin.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.I have another cancer, but it won't affect this trial's treatment.I cannot or will not take pills.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am not taking any strong CYP3A4 inhibitors or inducers, or can stop them 7 days before starting ZEN-3694.More than a quarter of my bone marrow has been exposed to radiation.I have a confirmed mutation related to my cancer and agree to share my test results.I can take care of myself but might not be able to do heavy physical work.I have chronic hepatitis B but my viral load is undetectable with treatment.I have had at least one treatment for my advanced cancer, or there are no treatments known to work for my condition.I had brain metastases but am stable now without steroids for 2 weeks.I have a digestive issue that affects how my body absorbs medication.I am 18 years old or older.I am not pregnant or have had surgery or am menopausal to prevent pregnancy.I finished my last cancer treatment over 4 weeks ago and have recovered from its side effects.I do not have an active infection needing IV antibiotics or any severe illness requiring hospitalization.My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.I am not pregnant or breastfeeding.I am allergic to medications similar to ZEN-3694 or talazoparib.I am HIV positive, on treatment, and my viral load is undetectable.I have a specific gene mutation and my last treatment was with PARPi.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ZEN-3694, talazoparib)
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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