Your session is about to expire
← Back to Search
Monoclonal Antibodies
DKN-01 for Colorectal Cancer (DeFianCe Trial)
Phase 2
Recruiting
Research Sponsored by Leap Therapeutics, 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 approximately 6 months
Awards & highlights
DeFianCe Trial Summary
This trial is testing a new cancer drug, DKN-01, to see if it is more effective than the current standard of care for treating advanced colorectal cancer.
Who is the study for?
Adults with advanced colorectal cancer (CRC) who've seen their disease progress after one line of systemic treatment. They must not have had certain prior treatments depending on the trial group they're assigned to, and should be in good physical condition (ECOG ≤1). Participants need measurable tumors and adequate organ function. Women of childbearing age and male partners must use contraception.Check my eligibility
What is being tested?
The study is testing DKN-01 in combination with chemotherapy regimens FOLFIRI or FOLFOX plus bevacizumab against standard care for second-line treatment of CRC. It's a Phase 2 trial where patients are randomly chosen to receive either the test combo or the standard therapy.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection, and blood clots. Bevacizumab can cause high blood pressure, bleeding problems, slow wound healing. Specific side effects from DKN-01 are not detailed but may align with typical immune therapy reactions.
DeFianCe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Duration of Response (DoR)
Incidence of ≥Grade 3 related treatment-related adverse events (TRAEs).
Objective Response Rate (ORR)
+1 moreOther outcome measures
Disease control rate (DCR)
Durable clinical benefit (DCB)
Duration of Complete Response (DoCR)
+3 moreDeFianCe Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment4 Interventions
DKN-01 + FOLFIRI or FOLFOX + bevacizumab
Group II: ControlActive Control3 Interventions
FOLFIRI or FOLFOX + bevacizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFIRI
2005
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
FOLFOX
2009
Completed Phase 3
~4560
DKN-01
2015
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Leap Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
877 Total Patients Enrolled
Cynthia Sirard, MDStudy DirectorLeap Therapeutics, Inc.
2 Previous Clinical Trials
343 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer progressed after first-line treatment with a fluoropyrimidine-based regimen.I have not had radiation therapy in the last 14 days.I do not have severe heart disease, recent heart attack, or irregular heartbeat.I haven't had any cancer other than this one in the last 2 years.I do not have active brain cancer spread or uncontrolled brain tumors.My colorectal cancer is MSI-H/dMMR or has a BRAF V600E mutation.I have not had radiation therapy in the last 14 days.I have a serious illness that is not cancer.I haven't had any cancer treatments in the last 28 days.I have previously received anti-VEGF or anti-EGFR therapy.My heart's electrical system has a known issue or my QTcF is over 470 msec.I agree to use birth control during and for 6 months after the study.I have not been treated with specific immune-targeting drugs.My liver, kidneys, blood, and clotting functions are all within normal ranges.I do not have any ongoing serious infections needing treatment.I am fully active or can carry out light work.My cancer has spread to my bones.I've had initial cancer treatment but my cancer worsened within a year.I have not received a live vaccine in the last 28 days.I have not had irinotecan as my first cancer treatment.I have not had oxaliplatin as my first treatment.I have enough tumor tissue available for testing.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.I have a history of hip bone disease or significant hip bone abnormalities.I have advanced colorectal cancer that has worsened after one treatment.I have not had major surgery in the last 28 days.I have not had major surgery in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
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.
How many people fit the bill to be able to join this study?
"Indeed, the trial is still recruiting patients if the information on clinicaltrials.gov is accurate. This experiment was first advertised on 8/30/2022 and updated on 9/16/2022. They are looking for 150 individuals total at a single location."
Answered by AI
Has this medication received government approval for general use?
"Because this is only a Phase 2 trial, and thus there is a lack of data when it comes to efficacy, we have given this treatment a safety score of 2."
Answered by AI
Who else is applying?
What site did they apply to?
Florida Cancer Specialists & Research Institute
Prisma Health Cancer Institute - Faris
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger