DKN-01 in Combination with Tislelizumab ± Chemotherapy in Patients with Gastric Cancer
What is the Purpose of this Study?
If you choose to join this study, you will:
- Go through a screening period to see if you're eligible for the study
- Have a tumor biopsy done, if necessary
If you're eligible to join, you will:
- Have physical exams
- Give blood samples
- Have other tests done during your clinic visits
- Be placed into 1 of 2 groups depending on when you join the study
-- Group A will receive study drugs DKN-01 and tislelizumab along with oxaliplatin IV once every 3 weeks and will take capecitabine by mouth twice a day for 2 weeks then hold for 1 week
-- Group B will receive study drugs DKN-01 and tislelizumab IV once every 3 weeks
- Go through a screening period to see if you're eligible for the study
- Have a tumor biopsy done, if necessary
If you're eligible to join, you will:
- Have physical exams
- Give blood samples
- Have other tests done during your clinic visits
- Be placed into 1 of 2 groups depending on when you join the study
-- Group A will receive study drugs DKN-01 and tislelizumab along with oxaliplatin IV once every 3 weeks and will take capecitabine by mouth twice a day for 2 weeks then hold for 1 week
-- Group B will receive study drugs DKN-01 and tislelizumab IV once every 3 weeks
What is the Condition Being Studied?
Advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
Who Can Participate in this Study?
Adults ages 18 and older who:
- Are diagnosed with gastric adenocarcinoma or GEJ adenocarcinoma
- Have not been previously treated with an anti-DKK1 therapy, PD-1, anti-PD-L1, or anti-PD-L-2 therapy
- Do not have known osteoblastic bony metastasis
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to learn more about how experimental drugs DKN-01 and tislelizumab work in your body and against your cancer. We will compare how these drugs works together and in combination with another drug combination called CAPOX (capecitabine and oxaliplatin).
Study Details
Full Title
[DEK-DKK1-P205] 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)
Principal Investigator
Contacts
Gastrointestinal Oncology DCI Clinical Research Team
Email: gi-oncology-cru@dm.duke.edu
Phone: +1 919-668-1861
Protocol Number
IRB:
PRO00105645
NCT:
NCT04363801
ClinicalTrials.gov
View on ClinicalTrials.gov