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Monoclonal Antibodies

Treatment (ZEN003694, cetuximab, encorafenib) for Colorectal Cancer

Phase 1
Recruiting
Led By Edmund S Kopetz
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing a new drug called ZEN003694 in combination with cetuximab and encorafenib to treat patients with colorectal cancer that has not responded to previous treatment and has

Who is the study for?
This trial is for adults over 18 with metastatic colorectal adenocarcinoma that's resistant to treatment and has a specific mutation (BRAF V600E). Participants need functioning liver and kidneys, an acceptable blood cell count, and if HIV-positive, must be on effective therapy with undetectable viral load.Check my eligibility
What is being tested?
The trial tests ZEN003694 combined with usual chemotherapy drugs cetuximab and encorafenib. It aims to find the safest dose of ZEN003694, see how well it works in treating refractory metastatic colorectal cancer compared to standard treatments alone.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation by cetuximab, organ function disruption from encorafenib, and unknown risks from the new drug ZEN003694 which may affect gene expression involved in tumor growth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (dose escalation cohort)
Recommended phase 2 dose (dose escalation cohort)
Secondary outcome measures
MAPK inhibition
Time to death
Time to progression
Other outcome measures
Presence or absence of a given gene mutation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ZEN003694, cetuximab, encorafenib)Experimental Treatment7 Interventions
Patients receive ZEN003694 PO QD on days 1-28 of each cycle, cetuximab IV over 120 minutes on days 1 and 15 of each cycle, and encorafenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood samples throughout the trial. Patients may also undergo biopsy at screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Biopsy
2014
Completed Phase 4
~1090
Encorafenib
2022
Completed Phase 3
~970
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,719 Previous Clinical Trials
40,963,503 Total Patients Enrolled
Edmund S KopetzPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
~20 spots leftby Jun 2025
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