Open Actively Recruiting

A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer


Brief Summary

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

Primary Purpose
Study Type
Phase II


Healthy Volunteers
Minimum Age
18 Years
Maximum Age
  • Part A:
    • No previous therapy for cancer. Patients may have received prior neoadjuvant or adjuvant therapy as long it was completed without disease recurrence for at least 6 months since last treatment.
  • Part B:
    • Disease progression during first-line therapy or within 4 months after the last dose of first-line therapy.
    • Documentation of elevated DKK1 mRNA expression from a fresh tumor biopsy or a biopsy obtained within the 6 months of screening.
  • Able to provide written informed consent prior to any study-specific procedures.
  • Confirmed diagnosis of gastric adenocarcinoma or GEJ adenocarcinoma.
  • One or more tumors measurable on radiographic imaging as defined by RECIST 1.1.
  • ECOG performance status ≤ 1 within 7 days of first dose of study drug
  • Acceptable liver, renal, hematologic, and coagulation function
  • Females of childbearing potential and male partners of female patients must agree to use adequate contraception during the study and for 6 months after their last dose of study drug. Exclusion:
  • Part A:
    • Diagnosis of HER2-positive G/GEJ adenocarcinoma.
    • Unable to swallow capsules or disease significantly affected gastrointestinal function (add diseases as examples).
  • Part B: a. Major surgery or chemotherapy within 21 days of first dose of study drug.
  • Patients with active autoimmune diseases or history of autoimmune diseases that may relapse.
  • Any condition that required treatment with steroids or any other immune suppressive drugs within 14 days prior to first dose of study drug.
  • Active leptomeningeal disease or uncontrolled brain metastases.
  • Any active cancer ≤ 2 years before first dose of study drug with the exception of cancer for this study.
  • New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
  • Fridericia-corrected QT interval (QTcF) > 470 msec (female) or history of congenital long QT syndrome.
  • Active, uncontrolled bacterial, viral, or fungal infections, within 14 days of study entry requiring systemic therapy.
  • Serious nonmalignant disease
  • Pregnant or nursing.
  • History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are symptomatic and clinically significant.
  • Known osteoblastic bony metastasis.
  • Major surgery 28 days prior to study entry.
  • Prior radiation therapy within 14 days prior to study entry.
  • Previously treated with an anti-DKK1 therapy, PD-1, anti-PD-L1, anti-PD-L-2
  • Significant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient.
  • Active substance abuse.
  • Known dihydropyrimidine dehydrogenase deficiency.
  • Administration of a live vaccine within 28 days before first dose of study drug.

Join this Trial

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Study Stats
Protocol No.
Lisa Yonemoto
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
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