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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

2021

Completed Phase 3

~960

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,411 Total Patients Enrolled

Edmund S KopetzPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently available to prospective participants?

"The search on clinicaltrials.gov confirms that patient recruitment is ongoing for this trial. The initial posting was on November 12, 2024, with the most recent update made on March 9, 2024."

Answered by AI

Has the FDA officially approved ZEN003694, cetuximab, and encorafenib for treatment purposes?

"The safety assessment of the treatment (ZEN003694, cetuximab, encorafenib) by our team at Power is rated as 1. This score reflects the preliminary stage of the trial with limited evidence supporting both safety and efficacy."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical trial?

"Indeed, as per the details on clinicaltrials.gov, this research is actively seeking participants. Originally shared on November 12th, 2024 and last revised on March 9th, 2024, the study aims to enroll 30 patients at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06102902.