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Monoclonal Antibodies
ZN-c3 Combo for Metastatic Colorectal Cancer
Phase 1 & 2
Recruiting
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation Phase - Incidence of Dose Limiting Toxicities (DLTs)
Dose Expansion Phase - Objective response rate (ORR)
Secondary outcome measures
Dose Escalation - Encorafenib plasma exposure: AUC
Dose Escalation - Encorafenib plasma exposure: Cmax
Dose Escalation - Encorafenib plasma exposure: Tmax
+29 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
Participants will receive recommended dose of ZN-c3 and encorafenib as determined in dose escalation phase in combination with cetuximab
Group II: Dose EscalationExperimental Treatment3 Interventions
Participants will receive different doses of ZN-c3 in combination with different doses of Encorafenib and a fixed dose of Cetuximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480
Encorafenib
2021
Completed Phase 3
~960
Find a Location
Who is running the clinical trial?
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
762 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,944 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver and kidneys are working well.I have not had another type of cancer in the past 2 years.My cancer has worsened after 1 or 2 treatments for its spread.I have received a transplant from another person.My bone marrow is working well.I have an active hepatitis B or C infection.My cancer has a BRAF V600E mutation.I have not had a serious infection in the last 2 weeks.I have a serious heart condition.I cannot swallow or absorb pills.I have lung inflammation not caused by an infection.My colorectal cancer is confirmed to be at stage IV.My cancer has spread to the lining of my brain and spinal cord.I have brain metastasis causing symptoms.I have pancreatitis.My cancer has worsened during the screening period.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
- Group 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are fresh participants being accepted for this experiment?
"Affirmative, clinicaltrials.gov states that this clinical study is actively recruiting participants. The trial was initiated on February 27th 2023 and has been updated as of March 8th 2023. 82 individuals are needed to be recruited from one medical centre for the experiment to commence."
Answered by AI
What is the scope of participants in this experiment?
"Affirmative. The clinical trials website confirms that this research is currently recruiting volunteers, with the original post date of February 27th 2023 and most recent update on March 8th 2023. 82 participants are needed from a single site."
Answered by AI
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