ZN-c3 Combo for Metastatic Colorectal Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

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 from first dose of any study intervention every 8 weeks during treatment, up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses the safety, tolerance and potential benefits of a new drug combo to treat metastatic colorectal cancer in adults with specific BRAF mutations.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, skin problems due to cetuximab; fatigue; digestive disturbances; blood-related issues; increased risk of infection from lowered immunity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of any study intervention every 8 weeks during treatment, up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of any study intervention every 8 weeks during treatment, up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of any study intervention every 8 weeks during treatment, up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose Escalation Phase - Incidence of Dose Limiting Toxicities (DLTs)

Dose Expansion Phase - Objective response rate (ORR)

Secondary study objectives

Dose Escalation Phase - Disease Control Rate (DCR)

Dose Escalation Phase - Duration of Response (DOR)

Dose Escalation Phase - Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

+8 more