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

COMPLETEDPHASE1

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

NCT02375880•Leap Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder.
•2. Patient must have sufficient tumor tissue available for submission.
•3. For patients who have received prior cryotherapy, radiofrequency ablation, radioembolization, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, at least 28 days must have elapsed since that therapy, and lesions that have not been treated with local therapy must be present and measurable.
•4. Patients may have received prior adjuvant chemotherapy with gemcitabine with or without cisplatin, as long as 6 months have elapsed since last treatment.
•5. Patients must have one or more tumors measurable on radiographic imaging as defined by RECIST.
•6. ECOG PS of 0 or 1. Patients with an ECOG PS of 2 may be entered upon review and approval of the medical monitor.
•7. Estimated life expectancy of at least 3 months.
•8. Disease-free of active second/secondary or prior malignancies for ≥ 2 years with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
•9. Adequate hematological, renal, hepatic and coagulation laboratory test results.
•10. Women of child bearing potential and men must agree to use adequate contraception during the study and for 6 months after their last dose of study drug.
+2 more criteria

Exclusion Criteria

•1. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
•2. Have Fridericia-corrected QT interval (QTcF) \> 470 msec (female) or \> 450 (male), or history of congenital long QT syndrome.
•3. Active, uncontrolled bacterial, viral, or fungal infections.
•4. Known to be human immunodeficiency virus (HIV) positive or has untreated, active hepatitis B.
•5. History of major organ transplant.
•6. History of an autologous/allogenic bone marrow transplant.
•7. Serious nonmalignant disease.
•8. Pregnant or nursing.
•9. History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are symptomatic and clinically significant.
•10. Symptomatic central nervous system (CNS) malignancy or metastasis.
+5 more criteria

Locations (9)

University of Southern California

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

University Hospitals, Case Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Key Dates

Start Date

June 1, 2015

Primary Completion Date

July 1, 2018

Completion Date

July 1, 2018

Last Updated

August 3, 2025

Enrollment

ACTUAL participants

Conditions

Carcinoma of Intrahepatic and Extra-hepatic Biliary SystemCarcinoma of GallbladderBile Duct CancerCholangiocarcinoma

Interventions

DKN-01

DRUG

gemcitabine

DRUG

cisplatin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)

Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer

Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)

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