ZN-c3 Combo for Metastatic Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, and potential clinical benefits of ZN-c3 administered in combination with encorafenib and cetuximab in adult participants with metastatic BRAF V600E mutant colorectal cancer previously treated with one or two treatment regimens.

Eligibility Criteria

Adults with metastatic colorectal cancer that has a specific mutation (BRAF V600E) and who have tried 1 or 2 other treatments without success. They must have measurable disease, good bone marrow, liver, and kidney function. Not eligible if pregnant/breastfeeding, have serious heart issues, another cancer within the last 2 years, brain metastasis or certain infections.

Inclusion Criteria

My liver and kidneys are working well.

My cancer has worsened after 1 or 2 treatments for its spread.

My bone marrow is working well.

Exclusion Criteria

I have not had another type of cancer in the past 2 years.

I have received a transplant from another person.

I have an active hepatitis B or C infection.

Participant Groups

The trial is testing ZN-c3 in combination with encorafenib and cetuximab to see if they're safe together and can help patients whose colorectal cancer has spread. Participants will already have had previous treatments that didn't work well enough.

Group I: Dose Expansion Experimental Treatment 3 Interventions

Participants will receive recommended dose of ZN-c3 and encorafenib as determined in dose escalation phase in combination with cetuximab

Group II: Dose Escalation Experimental Treatment 3 Interventions

Participants will receive different doses of ZN-c3 in combination with different doses of Encorafenib and a fixed dose of Cetuximab

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erbitux for:

• Locally or regionally advanced squamous cell carcinoma of the head and neck
• Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
• K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
• BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for:

• Squamous cell carcinoma of the head and neck
• K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Alliance for Multispecialty Research, LLC Merriam, KS

USC Norris Comprehensive Cancer Center Los Angeles, CA

University of Texas MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc Lead Sponsor

Pfizer Industry Sponsor

References