RecruitingPhase IEN originalColorectal cancerMetastatic / advanced

Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer

⚠️

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, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that has spread from where it first started (primary site) to other places in the body (metastatic). ZEN003694 is a protein inhibitor that binds to BET proteins. When ZEN003694 binds to BET proteins, it disrupts gene expression. Preventing the expression of certain growth-promoting genes may inhibit proliferation of tumor cells that over-express BET proteins. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Encorafenib is an enzyme inhibitor. It inhibits pathways that are responsible for controlling cell proliferation and survival, which may lead to a decrease in tumor cell proliferation. Both cetuximab and encorafenib have been approved to treat cancer. Adding ZEN003694 to cetuximab and encorafenib may be more effective at treating patients with refractory metastatic colorectal cancer than giving the usual treatment (cetuximab and encorafenib) alone.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Potwierdzony rak jelita grubego, który rozprzestrzeniył się na inne części ciała, z mutacją genetyczną BRAF V600E
  • •Wiek co najmniej 18 lat
  • •Ogólny stan zdrowia umożliwiający leczenie (wynik ECOG 0-2)
  • •Wystarczająca liczba białych krwinek (neutrofile ≥ 1500/mcL)
  • •Wystarczająca liczba płytek krwi (≥ 100 000/mcL)
  • •Hemoglobina co najmniej 9 mg/dl
  • •Prawidłowe funkcje wątroby i nerek
  • •Pacjenci z HIV lub zapaleniem wątroby mogą uczestniczyć, jeśli są skutecznie leczeni

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 23, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (16)

UC Irvine Health Cancer Center-Newport

Costa Mesa, United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, United States

Los Angeles General Medical Center

Los Angeles, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, United States

UCHealth University of Colorado Hospital

Aurora, United States

University of Kansas Clinical Research Center

Fairway, United States

University of Kansas Cancer Center

Kansas City, United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, United States

Ochsner Medical Center Jefferson

New Orleans, United States

Ohio State University Comprehensive Cancer Center

Columbus, United States

University of Oklahoma Health Sciences Center

Oklahoma City, United States

UT MD Anderson Cancer Center

Houston, United States

University of Virginia Cancer Center

Charlottesville, United States

VCU Massey Comprehensive Cancer Center

Richmond, United States

Trial contact

Site Public Contact

Farshid Dayyani

PRINCIPAL_INVESTIGATOR

Site Public Contact

Site Public Contact

Heinz-Josef Lenz

PRINCIPAL_INVESTIGATOR

Site Public Contact

Alexis D. Leal

PRINCIPAL_INVESTIGATOR

Shafia Rahman

PRINCIPAL_INVESTIGATOR

Susanna V. Ulahannan

PRINCIPAL_INVESTIGATOR

Salvador Alonso Martinez

PRINCIPAL_INVESTIGATOR

Paul Kunk

PRINCIPAL_INVESTIGATOR

Khalid Matin

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/11/2026.

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