DKN-01 for Colorectal Cancer
(DeFianCe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, DKN-01, combined with standard chemotherapy and bevacizumab for advanced colorectal cancer patients who didn't respond to earlier treatment. The treatment works by attacking cancer cells, blocking growth signals, and cutting off their blood supply.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot have had systemic anti-cancer therapy within 28 days before starting the study drug.
Is DKN-01 (also known as Bevacizumab or Avastin) safe for use in humans?
Bevacizumab (Avastin) is generally safe when used with chemotherapy for metastatic colorectal cancer, but it can cause side effects like high blood pressure, protein in urine, blood clots, wound-healing issues, bleeding, and gastrointestinal perforation. These side effects are manageable with proper medical care.12345
What makes the drug DKN-01 unique for treating colorectal cancer?
Who Is on the Research Team?
Cynthia Sirard, MD
Principal Investigator
Leap Therapeutics, Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DKN-01 plus FOLFIRI/FOLFOX and bevacizumab or standard of care (SOC) as second-line treatment
Safety Follow-up
Participants are monitored for safety approximately 30 days after the last administration of study drug
Long-Term Follow-up
Participants are followed for survival, subsequent therapies, and disease progression if applicable
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- DKN-01
- FOLFIRI
- FOLFOX
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Leap Therapeutics, Inc.
Lead Sponsor