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Alkylating agents

150 mg DKN-01 Part A for Bile Duct Cancer

Phase 1
Waitlist Available
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 cycle 1 - days 1 and 8, cycle 2 - day 1
Awards & highlights

Summary

DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and is being developed as an anti-neoplastic agent. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of DKN-01 in combination with gemcitabine and cisplatin in patients with carcinoma primary to the intra- or exta-hepatic biliary system or gallbladder.

Eligible Conditions
  • Bile Duct Cancer
  • Cholangiocarcinoma
  • Gallbladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 - days 1 and 8, cycle 2 - day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 - days 1 and 8, cycle 2 - day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose and dose-limiting toxicities as determined in Part A.
Secondary outcome measures
Efficacy - Response to treatment evaluated using the Response Evaluation Criteria in Solid Tumors guidelines (RECIST 1.1)
Pharmacokinetics - AUC
Pharmacokinetics - Cmax
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: MTD mg DKN-01 Part BExperimental Treatment3 Interventions
Patients are treated at the maximum tolerated dose (MTD) of DKN-01 (or highest dose tested in Part A if the MTD is not defined) followed by gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on Days 1 and 8 of each 21-day cycle.
Group II: 300 mg DKN-01 Part AExperimental Treatment3 Interventions
Patients will receive 300 mg of DKN-01 followed by gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on Days 1 and 8 of each 21-day cycle.
Group III: 150 mg DKN-01 Part AExperimental Treatment3 Interventions
Patients will receive 150 mg of DKN-01 followed by gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on Days 1 and 8 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
DKN-01
2015
Completed Phase 1
~90
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

Leap Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,026 Total Patients Enrolled
~5 spots leftby Sep 2025
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