Phase 2 Study of DKN-01 for Treating Colorectal Cancer
Sponsor: Leap Therapeutics, Inc.
ClinicalTrials ID:NCT05480306
This clinical trial is testing a new treatment called DKN-01, combined with standard chemotherapy and bevacizumab, to see if it works better than the usual treatment for advanced colorectal cancer. The study is for patients whose cancer has worsened after initial treatment.
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Program Overview
This study is exploring whether adding a new drug, DKN-01, to standard chemotherapy and bevacizumab can improve treatment outcomes for patients with advanced colorectal cancer. The trial is divided into two parts and involves about 200 adult patients whose cancer has progressed after their first treatment. Participants will go through a screening process, receive treatment, and be monitored for safety and effectiveness. After treatment, they will be followed up to check their health and any further treatments they receive.
Description
This clinical trial is designed to test the effectiveness and safety of a new drug, DKN-01, when combined with standard chemotherapy treatments (FOLFIRI or FOLFOX) and bevacizumab for patients with advanced colorectal cancer. The study is divided into two parts and will include about 200 adult patients whose cancer has worsened after their first treatment.
Participants will go through several stages: a screening period to determine eligibility, a treatment period where they receive the study drugs, a safety follow-up period to monitor any side effects, and a long-term follow-up period to track their health and any additional treatments they may receive. Patients who stop the study treatment for reasons other than cancer progression will also be monitored for any changes in their cancer.
The study aims to find out if the new combination of treatments can better control the cancer compared to the standard treatment alone.
Eligibility Criteria
Inclusion Criteria
- Cancer has worsened after first-line treatment with a specific type of chemotherapy for advanced disease.
- May have had previous treatments that included irinotecan or oxaliplatin, but not both.
- Can provide written consent to participate in the study.
- Have at least one tumor that can be measured by scans.
- Have enough tumor tissue available for testing before treatment.
- Be in good overall health with a performance status score of 0 or 1.
- Have acceptable liver, kidney, blood, and clotting function.
- Women who can become pregnant and male partners of female patients must agree to use effective birth control during the study and for six months after the last dose.
Exclusion Criteria
- Have a specific type of colorectal cancer with certain genetic mutations.
- Have had previous treatments targeting specific immune checkpoints or certain chemotherapy combinations.
- Have received cancer treatment, major surgery, or radiation therapy recently.
- Have active or uncontrolled brain cancer or other serious health conditions.
- Have had another active cancer within the last two years, except for the cancer being studied.
- Have serious heart conditions or abnormal heart rhythms.
- Have active infections or other serious non-cancerous diseases.
- Are pregnant or breastfeeding.
- Have a history of bone problems or certain bone metastases.
- Have significant allergies to medications or active substance abuse.
- Have a known deficiency in a specific enzyme related to drug metabolism.
- Have received a live vaccine recently.
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