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New hope for stomach cancer: experimental drug combo trial opens

NCT ID NCT06469944

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 5 times

Summary

This study tests new experimental drugs combined with standard chemotherapy and immunotherapy for people with advanced stomach, gastroesophageal junction, or esophageal cancer that cannot be removed by surgery or has spread. About 160 participants will receive the combination to see if it is safe and helps shrink tumors. The goal is to find better treatment options for this hard-to-treat cancer.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2029

An estimate. End dates often move.

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 Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma * Is not expected to require tumor resection during the treatment course * Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines * Core/excisional biopsy of a tumor lesion not previously irradiated has been provided * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline * Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible * Has adequate organ function * Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blinded independent central review (BICR) * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention * Has a life expectancy of at least 6 months * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation/randomization * Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has squamous cell or undifferentiated gastroesophageal cancer. * Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma * Has experienced weight loss \>20% over 3 months before the first dose of study intervention * Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has Grade ≥2 peripheral neuropathy * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention * Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment * Has history of human immunodeficiency virus (HIV) infection with Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted or anti-human epidermal growth factor receptor 3 (HER3) targeted agents * Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) and/or a topoisomerase I inhibitor-based chemotherapy * Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention * Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR) * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening * Has an active infection requiring systemic therapy * Has concurrent active hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] positive and/or detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus \[HCV\] Ab positive and detectable HCV ribonucleic acid \[RNA\] infection or a known history of hepatitis B and/or C infection * Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study * Has gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication * Has poorly controlled diarrhea * Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention * Has history of allogeneic tissue/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 esophageal adenocarcinoma esophageal cancer Esophageal Neoplasms gastric adenocarcinoma gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma neoplasm of esophagus

As listed by the trial registrant

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

Esophageal cancer Esophageal neoplasms Gastroesophageal adenocarcinoma Gastroesophageal junction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    47 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center-Department of Oncology ( Site 5901)

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria Pisana ( Site 5206)

    RECRUITING

    Pisa, Tuscany, 56126, Italy

  • Beijing Cancer hospital-Digestive Oncology ( Site 5500)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Bradford Hill Norte ( Site 6407)

    RECRUITING

    Antofagasta, 1263521, Chile

  • Bradfordhill-Clinical Area ( Site 6401)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CHU-BREST Cavale Blanche ( Site 5104)

    RECRUITING

    Brest, Finistere, 29200, France

  • CIC. ( Site 5100)

    RECRUITING

    Lille, Nord, 59037, France

  • Centro de Investigación del Maule ( Site 6408)

    RECRUITING

    Talca, Maule Region, 3481349, Chile

  • Centro de Oncología de Precisión-Oncology ( Site 6404)

    RECRUITING

    Santiago, Region M. de Santiago, 7560908, Chile

  • China Medical University Hospital ( Site 6007)

    RECRUITING

    Taichung, 404, Taiwan

  • Chulalongkorn Hospital ( Site 6104)

    RECRUITING

    Pathumwan, Bangkok, 10330, Thailand

  • Clínica Puerto Montt ( Site 6409)

    RECRUITING

    Port Montt, Los Lagos Region, 5500243, Chile

  • Clínica UC San Carlos de Apoquindo ( Site 6405)

    RECRUITING

    Santiago, Region M. de Santiago, 7620002, Chile

  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)

    COMPLETED

    New York, New York, 10032, United States

  • FALP-UIDO ( Site 6400)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine Siriraj Hospital ( Site 6102)

    RECRUITING

    Bangkoknoi, Bangkok, 10700, Thailand

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fudan University Shanghai Cancer Center ( Site 5513)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 6807)

    RECRUITING

    Erdgeschoss, Free and Hanseatic City of Hamburg, 22297, Germany

  • Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Henan Cancer Hospital ( Site 5504)

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hospital Nossa Senhora da Conceição ( Site 6301)

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hôpitaux Universitaires de Genève (HUG) ( Site 6701)

    RECRUITING

    Geneva, Canton of Geneva, 1211, Switzerland

  • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)

    RECRUITING

    São Paulo, 03102-006, Brazil

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)

    RECRUITING

    São Paulo, 01246-000, Brazil

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207)

    RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

  • Kantonsspital Graubünden-Medizin ( Site 6700)

    RECRUITING

    Chur, Kanton Graubünden, 7000, Switzerland

  • Liga Norte Riograndense Contra o Câncer ( Site 6303)

    RECRUITING

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • NCT-Department of Medical Oncology ( Site 6809)

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • National Cheng Kung University Hospital ( Site 6001)

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital-Oncology ( Site 6000)

    RECRUITING

    Taipei, 10048, Taiwan

  • Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)

    COMPLETED

    Louisville, Kentucky, 40202, United States

  • Oslo universitetssykehus, Radiumhospitalet ( Site 6501)

    RECRUITING

    Oslo, 0379, Norway

  • Ospedale San Raffaele-Oncologia Medica ( Site 5202)

    RECRUITING

    Milan, 20132, Italy

  • Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)

    RECRUITING

    Paris, Île-de-France Region, 75013, France

  • Ramathibodi Hospital ( Site 6103)

    RECRUITING

    Ratchathewi, Bangkok, 10400, Thailand

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)

    RECRUITING

    Seoul, 06351, South Korea

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • Songklanagarind hospital ( Site 6101)

    RECRUITING

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Taipei Veterans General Hospital ( Site 6005)

    RECRUITING

    Taipei, 112, Taiwan

  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)

    RECRUITING

    Fuzhou, Fujian, 350025, China

  • The Cancer and Hematology Centers ( Site 6912)

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • The First Affiliated Hospital of Nanchang University ( Site 5514)

    RECRUITING

    Nanchang, Jiangxi, 330000, China

  • The First Affiliated hospital of Xiamen University ( Site 5503)

    RECRUITING

    Xiamen, Fujian, 361003, China

  • UCLA Hematology/Oncology - Santa Monica ( Site 6905)

    RECRUITING

    Los Angeles, California, 90404, United States

  • UPMC Hillman Cancer Center-UPMC ( Site 6904)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Texas MD Anderson Cancer Center ( Site 6920)

    RECRUITING

    Houston, Texas, 77030, United States

  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)

    ACTIVE_NOT_RECRUITING

    Ürümqi, Xinjiang, 841100, China

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