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Stomach cancer drug combo trial halted midway

NCT ID NCT04363801

Disease control Sponsor: Leap Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called DKN-01 combined with tislelizumab and chemotherapy for people with advanced stomach or gastroesophageal junction cancer that could not be removed by surgery. The trial enrolled 247 adults who had not received prior treatment or whose cancer had worsened after first-line therapy. The study was terminated early, so results are limited, but the goal was to see if the combination could slow cancer growth and improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

247 people

The number who actually took part.

Started

Jul 2020

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion: Part A \& C: 1. 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 Only: 2. Disease progression during first-line therapy or within 4 months after the last dose of first-line therapy. 3. Documentation of elevated Dickkopf-1 (DKK1) messenger ribonucleic acid (mRNA) expression from a fresh tumor biopsy or a biopsy obtained within the 6 months of screening. Part C Only: 4. Documentation of programmed cell death protein ligand-1 (PD-L1) combined positive score (CPS) by immunohistochemistry (IHC) and DKK1 mRNA expression in tumor cells by ISH from a fresh tumor biopsy (preferred) or archived tumor biopsy specimen conducted in a Sponsor designated central laboratory. General: 5. Able to provide written informed consent prior to any study-specific procedures. 6. Age ≥18 years on the day of signing the informed consent (exception: ≥19 years in the Republic of Korea). 7. Confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma. 8. One or more tumors measurable on radiographic imaging as defined by Response Evaluation Criteria in Solid Tumor (RECIST) 1.1. 9. Tumor tissue for mandatory pre-treatment evaluation (fresh biopsy \[preferred\] or archived specimen). 10. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 within 7 days of first dose of study drug 11. Acceptable liver, renal, hematologic, and coagulation function 12. 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. 13. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for at least 6 months after the last dose of study drugs. Exclusion: Part A \& C Only: 1. Diagnosis of HER2-positive G/GEJ adenocarcinoma. 2. Unable to swallow capsules or disease significantly affected gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction (for those receiving CAPOX in Part C). 3. Prior therapy with an anti-programmed cell death protein 1 (PD-1) or anti-PD-L1 antibody. Part B Only: 4. Major surgery or chemotherapy within 21 days of first dose of study drug. General: 5. Squamous cell or undifferentiated or other histological type of gastric cancer. 6. Prior therapy with an anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or co-inhibitory checkpoint pathways in any treatment setting (including adjuvant/neoadjuvant) or prior therapy with an anti-DKK1 agent. 7. Patients with active autoimmune diseases or history of autoimmune diseases that may relapse. 8. Any condition that required treatment with steroids or any other immune suppressive drugs within 14 days prior to first dose of study drug. 9. Active leptomeningeal disease or uncontrolled brain metastases. 10. Any active cancer ≤ 2 years before first dose of study drug with the exception of cancer for this study. 11. Uncontrolled diabetes or \>Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥Grade 3 hypoalbuminemia within 14 days before first dose of study drug. 12. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage within 7 days prior to first dose of study drug. 13. Clinically significant anorexia within 7 days prior to first dose of study drug. 14. History of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung disease, or uncontrolled systemic diseases. 15. Active, uncontrolled bacterial, viral, or fungal infections, within 14 days of study entry requiring systemic therapy. 16. Prior allogeneic stem cell transplantation or organ transplantation. 17. History of severe hypersensitivity reactions to other monoclonal antibodies or any components of study treatment. 18. Known dihydropyrimidine dehydrogenase deficiency. 19. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia. 20. Fridericia-corrected QT interval (QTcF) \> 470 msec (female) or history of congenital long QT syndrome. 21. Known to be human immunodeficiency virus (HIV) positive. 22. Serious nonmalignant disease 23. History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on magnetic resonance imaging (MRI) scan that are symptomatic and clinically significant. 24. Known osteoblastic bony metastasis. 25. History of gastrointestinal perforation and/or fistulae within 6 months prior to first dose of study drug. 26. Major surgery 28 days prior to study entry. 27. Serious psychiatric or medical conditions that could interfere with treatment. 28. Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for Adverse Events (AEs) not considered a likely safety risk (e.g., alopecia, neuropathy, and specific laboratory abnormalities). 29. Administration of a live vaccine within 28 days before first dose of study drug. 30. Active substance abuse. 31. Pregnant or nursing. 32. Concurrent participation in another therapeutic clinical study. 33. Prior radiation therapy within 14 days prior to study entry.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric adenocarcinoma Gastric cancer Gastroesophageal cancer

Contacts and locations

Locations

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Boramae Hospital SNU

    Seoul, 07061, South Korea

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13520, South Korea

  • Caritas Klinikum Saarbrücken St. Theresia

    Saarbrücken, 66113, Germany

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868, United States

  • Charité Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • City of Hope

    Duarte, California, 91010, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dong-A University Hospital

    Busan, 49201, South Korea

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Hallym University Sacred Heart Hospital

    Anyang, 14068, South Korea

  • Hanyang University Hospital

    Seoul, 04763, South Korea

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Hämatologisch-Onkologische Praxis Eppendorf (HOPE)

    Hamburg, 20249, Germany

  • Inha University Hospital

    Incheon, 22332, South Korea

  • Institut Fur Klinisch Onkologische Forschung Am Krankenhaus Nordwest

    Frankfurt, 60488, Germany

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Korea University Ansan Hospital

    Ansan-si, 15355, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Cancer Center

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • National Cancer Center

    Goyang, 10408, South Korea

  • Northwestern University Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611, United States

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722, South Korea

  • Slk-Kliniken

    Heilbronn, 74078, Germany

  • Studienzentrum Onkologie Ravensburg

    Ravensburg, 88212, Germany

  • The Angeles Clinic Research Institute - A Cedars-Sinai Affiliate

    Los Angeles, California, 90025, United States

  • The Catholic University of Korea St. Mary's Hospital

    Seoul, 6591, South Korea

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 16247, South Korea

  • UCLA

    Los Angeles, California, 90095, United States

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.