Ph2StudyOf DKN-01+Tislelizumab±ChemotherapyInPatientsWithGastricCancer

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)

• IRAS ID

  1006876

• Contact name

  Christine Granfield

• Contact email

  regulatory@leaptx.com

• Sponsor organisation

  Leap Therapeutics, Inc.

• Eudract number

  2022-501471-10

• Clinicaltrials.gov Identifier

  NCT04363801

• Research summary

  This research study tests an investigational drug called DKN-01 combined with another investigational drug called tislelizumab and a combination of other approved drugs, either capecitabine and oxaliplatin (CAPOX) OR leucovorin calcium, fluorouracil, and oxaliplatin (mFOLFOX6). Patients can be randomly assigned to the group taking DKN-01 or the groups receiving investigational drug tislelizumab combined with either CAPOX or mFOLFOX6. The combination of the drugs is also investigational.
  Participating patients have advanced gastric or gastroesophageal junction (GEJ) cancer and standard drugs to treat their disease may not be effective, or no effective treatment is known for their disease.
  The purpose of this study is to find out if combining DKN-01 with tislelizumab and CAPOX (capecitabine + oxaliplatin) or mFOLFOX6 (leucovorin calcium + fluorouracil + oxaliplatin) will be safe and if it will delay the chance of patients' cancer growing or spreading. There are three parts to this study. Patients are being asked to participate in Part C. Approximately 160 subjects will participate in this part of the study. Parts A and B have treated 78 subjects and are no longer open for subjects to join.

• REC name

  Wales REC 2

• REC reference

  23/WA/0078

• Date of REC Opinion

  7 Sep 2023

• REC opinion

  Further Information Unfavourable Opinion