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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from treatment start date
Awards & highlights

Study 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.

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
~1190
Binimetinib
2018
Completed Phase 3
~1100
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,640 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer
2022. "Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05111561.
~14 spots leftby Mar 2025
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