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Monoclonal Antibodies

ZEN003694 + Chemotherapy 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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (dose escalation cohort)

Recommended phase 2 dose (dose escalation cohort)

Secondary study objectives

MAPK inhibition

Time to death

Time to progression

Other study objectives

Presence or absence of a given gene mutation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ZEN003694, cetuximab, encorafenib)Experimental Treatment9 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 ECHO or MUGA, 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

Echocardiography

2013

Completed Phase 4

~11580

Multigated Acquisition Scan

2015

Completed Phase 3

~270