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

Phase 1 Completed 51 enrolled Leap Therapeutics, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2015-06
Primary completion: 2018-07
Completion: 2018-07

Publications

Goyal L, Sirard C, Schrag M, Kagey MH, Eads JR, Stein S, El-Khoueiry AB, Manji GA, Abrams TA, Khorana AA, Miksad R, Mahalingam D, Zhu AX, Duda DG. Phase I and Biomarker Study of the Wnt Pathway Modulator DKN-01 in Combination with Gemcitabine/Cisplatin in Advanced Biliary Tract Cancer. Clin Cancer Res. 2020 Dec 1;26(23):6158-6167. doi: 10.1158/1078-0432.CCR-20-1310. Epub 2020 Sep 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DKN-01	Monoclonal antibody	150 mg	Intravenous
Subject	DKN-01	Monoclonal antibody	300 mg	Intravenous
Background	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications