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BET Bromodomain Inhibitor

ZEN003694 + Binimetinib for Advanced Solid Cancers

Phase 1
Recruiting
Led By Sarina A Piha-Paul
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
Age >= 18 years
Patients must have histologically confirmed advanced/metastatic or unresectable solid tumor that is refractory to standard therapy or has relapsed after standard therapy
Must not have
Patients with uncontrolled intercurrent illness
Prior therapy with specific inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from treatment start date
Awards & highlights

Summary

This trial is testing the safety and effectiveness of combining two drugs, ZEN003694 and binimetinib, to treat patients with solid tumors that have spread or can't be removed by surgery.

Who is the study for?
Adults with advanced/metastatic or unresectable solid tumors that have specific RAS alterations, including triple negative breast cancer. Participants must be in a stable condition, not pregnant or breastfeeding, and willing to use contraception. They should be beyond certain periods after previous treatments and agree to sign informed consent.Check my eligibility
What is being tested?
The trial is testing the combination of ZEN003694 (a BET protein inhibitor) and binimetinib (a kinase inhibitor) on patients with solid tumors having RAS mutations. The study has two parts: finding the best dose without severe side effects and then giving this dose to more people to learn about its safety.See study design
What are the potential side effects?
Potential side effects include issues related to organ inflammation, digestive system disturbances, blood disorders, fatigue, increased risk of infection due to immune system suppression, as well as possible reactions at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is advanced, cannot be surgically removed, and has not responded to standard treatments.
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My heart condition allows me to perform physical activities with slight limitations.
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I can take care of myself but might not be able to do heavy physical work.
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I have triple negative breast cancer or a solid tumor with specific genetic changes.
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I haven't had chemotherapy, radiotherapy, or investigational therapy for at least 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any unmanaged ongoing illnesses.
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I have previously been treated with specific inhibitors.
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My cancer does not have PI3K pathway mutations.
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I do not have any conditions that affect how my body absorbs pills.
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I have had a stroke, heart attack, or severe chest pain in the last 6 months.
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My breast cancer has never been hormone receptor positive.
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I have had a blockage in the vein of my eye.
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I have had pneumonitis or lung disease affecting the tissue and space around the air sacs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from treatment start date
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from treatment start date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (Part 2 [Dose Expansion])
Incidence of dose limiting toxicities (Part 1 [Dose Escalation])
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Incidence of adverse events (AEs) (Part 1 [Dose Escalation])
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ZEN-3694, binimetinib)Experimental Treatment6 Interventions
Patients receive ZEN-3694 PO QD and binimetinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. During the dose expansion phase, patients will have two mandatory biopsies - one before beginning the study and the second at day 15 of cycle 1. The study biopsy takes small pieces of cancer tissue from patient's body to look for markers (substances made by, on, or in tumor cells) related to how the study treatment works. Patients also undergo collection of blood samples at screening and on study and undergo CT or MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Binimetinib
2018
Completed Phase 3
~1100
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720

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, like ZEN003694, work by targeting bromodomain and extra-terminal proteins that regulate genes essential for cancer cell growth and survival. MEK inhibitors, such as Binimetinib, block the MEK1 and MEK2 proteins in the MAPK/ERK pathway, which is often overactive in cancer cells, leading to uncontrolled proliferation. These targeted therapies are important for cancer patients because they can more precisely disrupt the specific pathways driving their cancer, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
How to Treat HR+/HER2- Metastatic Breast Cancer Patients after CDK4/6 Inhibitors: An Unfinished Story.New and emerging combination therapies for esophageal cancer.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,359 Total Patients Enrolled
Sarina A Piha-PaulPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
4 Previous Clinical Trials
408 Total Patients Enrolled

Media Library

BET Bromodomain Inhibitor ZEN-3694 (BET Bromodomain Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05111561 — Phase 1
Cancer Research Study Groups: Treatment (ZEN-3694, binimetinib)
Cancer Clinical Trial 2023: BET Bromodomain Inhibitor ZEN-3694 Highlights & Side Effects. Trial Name: NCT05111561 — Phase 1
BET Bromodomain Inhibitor ZEN-3694 (BET Bromodomain Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05111561 — Phase 1
~9 spots leftby Mar 2025