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

Completed · Phase 1

Conditions studied: Carcinoma of Intrahepatic and Extra-hepatic Biliary System, Carcinoma of Gallbladder, Bile Duct Cancer, Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT02375880

Run by

Leap Therapeutics, Inc.

People needed

51

Starts

2015-06-01

Expected to finish

2018-07-01

Last updated by the study team

2025-08-03

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder.
• Patient must have sufficient tumor tissue available for submission.
• 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.
• Patients may have received prior adjuvant chemotherapy with gemcitabine with or without cisplatin, as long as 6 months have elapsed since last treatment.
• Patients must have one or more tumors measurable on radiographic imaging as defined by RECIST.
• ECOG PS of 0 or 1. Patients with an ECOG PS of 2 may be entered upon review and approval of the medical monitor.
• Estimated life expectancy of at least 3 months.
• 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.
• Adequate hematological, renal, hepatic and coagulation laboratory test results.
• 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.
• Available for the duration of the study and are willing to follow study-specific procedures.
• Provide written informed consent

You may not qualify if…

• New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
• Have Fridericia-corrected QT interval (QTcF) > 470 msec (female) or > 450 (male), or history of congenital long QT syndrome.
• Active, uncontrolled bacterial, viral, or fungal infections.
• Known to be human immunodeficiency virus (HIV) positive or has untreated, active hepatitis B.
• History of major organ transplant.
• History of an autologous/allogenic bone marrow transplant.
• Serious nonmalignant disease.
• Pregnant or nursing.
• 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.
• Symptomatic central nervous system (CNS) malignancy or metastasis.
• Clinically significant peripheral neuropathy
• Known osteoblastic bony metastasis.
• Treatment with surgery or chemotherapy within 21 days prior to study entry or radiation within 14 days of study entry.
• Previously treated with an anti-Dkk-1 therapy.
• Other exclusions apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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