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New hope for advanced stomach cancer: experimental drug combos enter human trials

NCT ID NCT06445972

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 5 times

Summary

This study tests two new drug combinations for people with advanced stomach, gastroesophageal junction, or esophageal cancer that has worsened after initial treatment. About 210 participants will receive either an experimental antibody-drug conjugate plus chemotherapy, or a standard targeted therapy plus chemotherapy. The goal is to see if the new combinations are safe and can shrink tumors or slow cancer growth.

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 210 people

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

Started

Aug 2024

Expected to finish

Aug 2030

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 treated, second line (2L) (received first line (1L) treatment) gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma * Has metastatic disease or locally advanced, unresectable disease * Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum/fluoropyrimidine doublet with or without immunotherapy * Tumor tissue must be confirmed as negative for HER2 expression (IHC 0/1+ or IHC2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines * Can provide a core/excisional biopsy of a tumor lesion not previously irradiated (collected from a biopsy performed after the most recent systemic anticancer therapy regimen) * AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable * Has Eastern Cooperative Oncology Group performance status of 0 or 1 * Has a life expectancy of at least 3 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 experienced weight loss \>20% over 3 months before the first dose of study intervention * Has 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 a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to allocation/randomization * Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to allocation/randomization * Has uncontrolled arterial hypertension ≥150/≥90 mm mercury (Hg) * Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment * Has undergone major surgery within 28 days prior to allocation/randomization, or central venous access device placement within 7 days prior to allocation/randomization or planned major surgery following initiation of study treatment * Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents * Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents * Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to allocation/randomization * Has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry * Has history of GI perforation and/or fistulae within 6 months prior to allocation/randomization * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)- or HER3-targeted agent, topoisomerase 1 inhibitor-based ADC and/or a topoisomerase 1 inhibitor-based chemotherapy, or any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or the vascular endothelial growth factor receptor (VEGFR) signaling pathways * Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention * 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. Administration of killed vaccines is allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded * Has known active central nervous system metastases and/or carcinomatous meningitis * Has an active infection requiring systemic therapy * Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid) infection * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ILD or pneumonitis cannot be ruled out by imaging at screening * Has severe hypersensitivity (Grade ≥3) to MK-2870, or HER3-DXd, any of their excipients, and/or to another biologic therapy * Has not adequately recovered from major surgery or have 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

    44 sites in 11 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 7901)

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria Pisana ( Site 7206)

    RECRUITING

    Pisa, Tuscany, 56126, Italy

  • Beijing Cancer hospital-Digestive Oncology ( Site 7500)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Bradford Hill Norte ( Site 8407)

    RECRUITING

    Antofagasta, 1263521, Chile

  • Bradfordhill-Clinical Area ( Site 8401)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CIC. ( Site 7100)

    RECRUITING

    Lille, Nord, 59037, France

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi ( Site 7104)

    RECRUITING

    Brest, Finistere, 29200, France

  • Centro de Investigación del Maule ( Site 8408)

    RECRUITING

    Talca, Maule Region, 3481349, Chile

  • Centro de Oncología de Precisión-Oncology ( Site 8404)

    RECRUITING

    Santiago, Region M. de Santiago, 7560908, Chile

  • China Medical University Hospital ( Site 8007)

    RECRUITING

    Taichung, 404332, Taiwan

  • Clínica Puerto Montt ( Site 8409)

    RECRUITING

    Port Montt, Los Lagos Region, 5500243, Chile

  • Clínica UC San Carlos de Apoquindo ( Site 8405)

    RECRUITING

    Santiago, Region M. de Santiago, 7620002, Chile

  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907)

    COMPLETED

    New York, New York, 10032, United States

  • FALP-UIDO ( Site 8400)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 7200)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fudan University Shanghai Cancer Center ( Site 7513)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 8807)

    RECRUITING

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

  • Hematology-Oncology Associates of Central NY, P.C. ( Site 8925)

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Henan Cancer Hospital ( Site 7504)

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hospital Nossa Senhora da Conceição ( Site 8301)

    RECRUITING

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

  • Hôpitaux Universitaires de Genève (HUG) ( Site 8701)

    RECRUITING

    Geneva, Canton of Geneva, 1211, Switzerland

  • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 8304)

    RECRUITING

    São Paulo, São Paulo, 03102-002, Brazil

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 8300)

    RECRUITING

    São Paulo, 01246-000, Brazil

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 7207)

    RECRUITING

    Meldola, Emilia-Romagna, 47014, Italy

  • Kantonsspital Graubünden-Medizin ( Site 8700)

    RECRUITING

    Chur, Kanton Graubünden, 7000, Switzerland

  • Liga Norte Riograndense Contra o Câncer ( Site 8303)

    RECRUITING

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

  • NCT-Department of Medical Oncology ( Site 8809)

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • National Cheng Kung University Hospital ( Site 8001)

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital-Oncology ( Site 8000)

    RECRUITING

    Taipei, 10048, Taiwan

  • Norton Cancer Institute - Downtown ( Site 8900)

    COMPLETED

    Louisville, Kentucky, 40202, United States

  • Oslo universitetssykehus, Radiumhospitalet ( Site 8501)

    RECRUITING

    Oslo, 0379, Norway

  • Ospedale San Raffaele-Oncologia Medica ( Site 7202)

    RECRUITING

    Milan, 20132, Italy

  • Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 7102)

    RECRUITING

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

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 7900)

    RECRUITING

    Seoul, 06351, South Korea

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 7510)

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • Taipei Veterans General Hospital ( Site 8005)

    RECRUITING

    Taipei, 112, Taiwan

  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 7501)

    RECRUITING

    Fuzhou, Fujian, 350025, China

  • The Cancer and Hematology Centers ( Site 8912)

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • The First Affiliated Hospital of Nanchang University ( Site 7514)

    RECRUITING

    Nanchang, Jiangxi, 330000, China

  • The First Affiliated hospital of Xiamen University ( Site 7503)

    RECRUITING

    Xiamen, Fujian, 361003, China

  • UCLA Hematology/Oncology - Santa Monica ( Site 8905)

    RECRUITING

    Los Angeles, California, 90404, United States

  • UPMC Hillman Cancer Center-UPMC ( Site 8904)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 8802)

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927)

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Texas MD Anderson Cancer Center ( Site 8920)

    RECRUITING

    Houston, Texas, 77030, United States

  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 7506)

    RECRUITING

    Ürümqi, Xinjiang, 841100, China

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