188 Participants Needed

DKN-01 for Colorectal Cancer

(DeFianCe Trial)

Recruiting at 44 trial locations
EP
CS
Overseen ByCynthia Sirard, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Leap Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

DKN-01 is unique because it targets a specific protein called DKK-1, which is involved in cancer growth, and is combined with other treatments like Bevacizumab and chemotherapy to potentially improve outcomes for colorectal cancer patients.34567

What data supports the effectiveness of the drug DKN-01 for colorectal cancer?

Research shows that bevacizumab, a component of the treatment, improves survival in patients with metastatic colorectal cancer when combined with chemotherapy, increasing median survival by 30% in one study.34589

Who Is on the Research Team?

CS

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

My cancer progressed after first-line treatment with a fluoropyrimidine-based regimen.
I have previously received anti-VEGF or anti-EGFR therapy.
I agree to use birth control during and for 6 months after the study.
See 9 more

Exclusion Criteria

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.
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DKN-01 plus FOLFIRI/FOLFOX and bevacizumab or standard of care (SOC) as second-line treatment

approximately 6 months

Safety Follow-up

Participants are monitored for safety approximately 30 days after the last administration of study drug

4-5 weeks

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
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment4 Interventions
Group II: ControlActive Control3 Interventions

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

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Approved in European Union as Avastin for:
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Approved in United States as Avastin for:
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Approved in Japan as Avastin for:
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Approved in Canada as Avastin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Leap Therapeutics, Inc.

Lead Sponsor

Trials
16
Recruited
1,100+

Published Research Related to This Trial

In a phase II trial involving 209 patients with metastatic colorectal cancer, the addition of bevacizumab to fluorouracil and leucovorin (FU/LV) significantly improved median progression-free survival to 9.2 months compared to 5.5 months with placebo, indicating a strong therapeutic benefit.
While bevacizumab treatment was associated with a higher incidence of grade 3 hypertension (16% vs. 3% in the placebo group), this side effect was manageable with medication and did not lead to discontinuation of the treatment, suggesting a favorable safety profile.
Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial.Kabbinavar, FF., Schulz, J., McCleod, M., et al.[2022]
In a combined analysis of three studies involving 490 patients, the addition of bevacizumab to FU/LV treatment resulted in a median overall survival of 17.9 months, compared to 14.6 months for the control group, indicating a significant survival benefit.
Patients receiving FU/LV with bevacizumab also experienced improved progression-free survival (8.8 months vs. 5.6 months) and a higher response rate (34.1% vs. 24.5%), demonstrating the efficacy of bevacizumab in treating metastatic colorectal cancer.
Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer.Kabbinavar, FF., Hambleton, J., Mass, RD., et al.[2022]
In a study involving 27 heavily pretreated patients with metastatic colorectal cancer, the combination of irinotecan, cetuximab, and bevacizumab was well tolerated and resulted in a progression-free survival (PFS) of 8.3 months and a median overall survival (mOS) of 12.0 months.
The addition of bevacizumab to the treatment regimen showed a trend towards improved outcomes in patients without KRAS mutations, suggesting that this combination therapy may be particularly effective for certain patient subgroups.
Bevacizumab in combination with cetuximab and irinotecan after failure of cetuximab and irinotecan in patients with metastatic colorectal cancer.Larsen, FO., Pfeiffer, P., Nielsen, D., et al.[2018]

Citations

Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial. [2022]
Bevacizumab in the treatment of colorectal cancer. [2019]
Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. [2022]
Bevacizumab in combination with cetuximab and irinotecan after failure of cetuximab and irinotecan in patients with metastatic colorectal cancer. [2018]
Chemotherapy, bevacizumab, and cetuximab in metastatic colorectal cancer. [2022]
Front-line bevacizumab in combination with oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX) in patients with metastatic colorectal cancer: a multicenter phase II study. [2018]
Managing patients with metastatic colorectal cancer on bevacizumab. [2015]
Combined treatment with bevacizumab and standard chemotherapy restores abnormal immune parameters in advanced colorectal cancer patients. [2021]
[Which role do new therapeutic options play in palliative care of colorectal cancer?]. [2018]
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