ZEN003694 + Binimetinib for Advanced Solid Cancers

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen bySarina A Piha-Paul

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing two drugs, ZEN003694 and binimetinib, to help stop the growth and spread of advanced cancers with specific genetic changes. Binimetinib targets patients whose cancers are hard to treat because they have spread or cannot be removed by surgery. The drugs work by blocking proteins and signals that cancer cells need to grow.

Research Team

Sarina A Piha-Paul

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Eligibility Criteria

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.

Inclusion Criteria

Your corrected QT interval must be less than 450 milliseconds.

My cancer's genetic changes were identified using advanced DNA testing.

I am 18 years old or older.

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Exclusion Criteria

Patients who are receiving any other investigational agents

Pregnant or breastfeeding women are excluded from this study

Patients with psychiatric illness/social situations that would limit compliance with study requirements

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Treatment Details

Interventions

BET Bromodomain Inhibitor ZEN-3694 (BET Bromodomain Inhibitor)
Binimetinib (Kinase Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.