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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT02375880

Public ClinicalTrials.gov record NCT02375880. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 10:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02375880
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Leap Therapeutics, Inc.
Industry
Enrollment
51 participants

Conditions and interventions

Eligibility (public fields only)

Age range
30 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2015 (Type not available)
Primary completion
Jul 2018 (Actual)
Completion
Jul 2018 (Actual)
Last update posted
Aug 3, 2025

2015 – 2018

United States locations

U.S. sites
9
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
University of Southern California Los Angeles California 90033 —
Yale University New Haven Connecticut 06520 —
Massachusetts General Hospital Boston Massachusetts 02214 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
Columbia University Medical Center New York New York 10032 —
University Hospitals, Case Medical Center Cleveland Ohio 44106 —
Cleveland Clinic Cleveland Ohio 44195 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02375880, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 3, 2025 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02375880 live on ClinicalTrials.gov.

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