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Terminated Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT04363801

Public ClinicalTrials.gov record NCT04363801. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 11, 2026, 9:26 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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)

Study identification

NCT ID
NCT04363801
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Leap Therapeutics, Inc.
Industry
Enrollment
247 participants

Conditions and interventions

Interventions

  • Capecitabine 1000mg/ m2 twice daily (BID) Drug
  • DKN-01 300mg Drug
  • DKN-01 400mg Drug
  • DKN-01 600mg Drug
  • Fluorouracil Drug
  • Leucovorin Calcium Drug
  • Oxaliplatin Drug
  • Tislelizumab 200mg Drug
  • Tislelizumab 400mg Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 28, 2020
Primary completion
Mar 30, 2025
Completion
Mar 30, 2025
Last update posted
Oct 8, 2025

2020 – 2025

United States locations

U.S. sites
23
U.S. states
12
U.S. cities
18
Facility City State ZIP Site status
Mayo Clinic Cancer Center Phoenix Arizona 85054
University of Arizona Tucson Arizona 85724
City of Hope Duarte California 91010
The Angeles Clinic Research Institute - A Cedars-Sinai Affiliate Los Angeles California 90025
University of Southern California Los Angeles California 90033
UCLA Los Angeles California 90095
Hoag Memorial Hospital Presbyterian Newport Beach California 92663
Chao Family Comprehensive Cancer Center, University of California, Irvine Orange California 92868
University of California San Francisco San Francisco California 94158
Mayo Clinic Florida Jacksonville Florida 32224
AdventHealth Cancer Institute Orlando Florida 32804
Northwestern University Robert H. Lurie Comprehensive Cancer Center Chicago Illinois 60611
University of Chicago Chicago Illinois 60637
Pontchartrain Cancer Center Covington Louisiana 70433
Massachusetts General Hospital Boston Massachusetts 02114
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Dana-Farber Cancer Institute Boston Massachusetts 02215
Columbia University Irving Medical Center New York New York 10032
Duke University Medical Center Durham North Carolina 27710
Fox Chase Cancer Center Philadelphia Pennsylvania 19111
Rhode Island Hospital Providence Rhode Island 02903
MD Anderson Cancer Center Houston Texas 77030
University of Wisconsin Carbone Cancer Center Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04363801, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 8, 2025 · Synced May 11, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04363801 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →