NCT02375880

Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder

A Dose Escalation and Cohort Expansion Study of DKN-01 in Combination With Gemcitabine and Cisplatin in Patients With Advanced Carcinoma Primary to the Intra- or Extra-hepatic Biliary System or Gallbladder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Leap Therapeutics, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In Part A, escalating doses of DKN-01 will be administered to different cohorts of patients to evaluate safety and dose limiting toxicities (DLTs) and to establish the maximum tolerated dose of DKN-01 when administered in combination with gemcitabine and cisplatin. Part B is an expansion cohort in which patients are treated at the MTD of DKN-01 (or highest dose tested if the MTD is not defined) to further characterize safety, tolerability, pharmacokinetics and efficacy within the defined patient population.

Conditions

• Carcinoma of Intrahepatic and Extra-hepatic Biliary System
• Carcinoma of Gallbladder
• Bile Duct Cancer
• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	DKN-01	Administration by intravenous (IV) infusion.
DRUG	gemcitabine	Administered by IV infusion.
DRUG	cisplatin	Administered by IV infusion

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2015-03-03
• Last updated: 2025-08-03

Locations

9 sites across 1 country: United States