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Study identifier: NCT05111561 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Advanced Malignant Solid Neoplasm · Metastatic Malignant Solid Neoplasm · Refractory Malignant Solid Neoplasm  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1
Planned participants42
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with binimetinib in treating patients with solid tumors that carry RAS alterations and that have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an oral medication with potential anticancer activity. It is an inhibitor of a family of proteins called bromodomain and extra-terminal (BET) which play important role during development and cellular growth. ZEN003694 may stop the growth of tumor cells that produce BET. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action proteins called MEK1 and MEK2, that signal cancer cells to multiply. It may help keep cancer cells from growing and spreading. There is pre-clinical evidence that using ZEN003694 and binimetinib together may shrink or stabilize cancers studied in this trial. There are two parts of this study; dose escalation and dose expansion. In the dose escalation part of this study, different people will get different doses of the study drugs ZEN003694 and binimetinib. In the dose expansion part of this study, the highest dose with manageable side effects will be given to additional people. This will help to understand the side effects that may happen with this drug combination.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (4)

Boston Medical CenterBoston, Massachusetts, United StatesActive Not Recruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesSuspended
University of Texas Medical BranchGalveston, Texas, United StatesRecruiting
UT MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05111561