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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony histologicznie zaawansowany lub rozprzestrzeniający się nowotwór stały, który nie reaguje na standardowe leczenie lub powrócił po leczeniu
  • Rak piersi potrójnie ujemny (TNBC) lub nowotwór z mutacją genów KRAS, NRAS, HRAS, BRAF lub innymi zmianami genetycznymi RAS
  • Zmiana genetyczna potwierdzona badaniem genetycznym (NGS)
  • Wiek co najmniej 18 lat
  • Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ECOG 0-2)
  • Wystarczająca liczba komórek krwi i prawidłowe funkcje wątroby i nerek
  • Przerwa co najmniej 4 tygodnie od poprzedniego leczenia chemioterapią lub innymi lekami przeciwnowotworowych
  • Przerwa co najmniej 4 tygodnie od ostatniej radioterapii

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 21, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (4)

Boston Medical Center

Boston, United States

Dana-Farber Cancer Institute

Boston, United States

University of Texas Medical Branch

Galveston, United States

UT MD Anderson Cancer Center

Houston, United States

Trial contact

Avi B. Markowitz

PRINCIPAL_INVESTIGATOR

Sarina A. Piha-Paul

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.

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