Summary of Clinical Use

Sirexatamab (DKN-01) has progressed to clinical evaluations in a range of advanced solid tumours and multiple myeloma.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT02375880	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 Interventional	Leap Therapeutics, Inc.	In this study a 300 mg dose of DKN-01 (in combination with and ) was well tolerated, but did not improve efficacy above that expected for the gemcitabine/cisplatin combination. An increased dose of 600 mg is under investigation.	1
NCT01457417	A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors	Phase 1 Interventional	Leap Therapeutics, Inc.
NCT04681248	Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors	Expanded Access	Leap Therapeutics, Inc.
NCT04057365	Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC)	Phase 2 Interventional	Massachusetts General Hospital
NCT03645980	DKN-01 Inhibition in Advanced Liver Cancer	Phase 1/Phase 2 Interventional	Johannes Gutenberg University Mainz
NCT00001693	Phase I-II Multiple-Dose Safety and Efficacy Study of a Selective Inhibitor of Cyclooxygenase - 2 (SC-58635) in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients and Carriers	Phase 1 Interventional	National Institutes of Health Clinical Center (CC)		4