DKN-01 in Combination with Tislelizumab +/- Chemotherapy in Patients with Gastric Cancer - Clinical Trial

What is the Purpose of this Study?

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).

What is the Condition Being Studied?

Advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma

Who Can Participate in the 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

What is Involved?

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

Study Details

Full Title
[DEK-DKK1-P205] A Phase 2a, 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
Medical Oncologist
Protocol Number
IRB: PRO00105645
NCT: NCT04363801
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698