Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Evaluation of Safety and Efficacy of MK-2870 and Paclitaxel in Second-Line Treatment of Advanced/Metastatic Gastroesophageal Adenocarcinoma

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for advanced gastroesophageal cancer, which includes cancers of the stomach and the area where the stomach meets the esophagus. The study is exploring the safety and effectiveness of a combination of medications, including MK-2870 and paclitaxel, as a second-line treatment. Second-line treatment refers to the therapy given when initial treatment (first-line) does not work or stops working. MK-2870 is a new investigational drug, while paclitaxel is a chemotherapy medication commonly used to treat various types of cancer.

The purpose of this study is to evaluate how safe and tolerable the combination of MK-2870 and chemotherapy is for patients. The study will also look at how well the treatment works in shrinking or controlling the cancer. Participants will receive the study medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will monitor participants for any side effects and measure how the cancer responds to the treatment over time.

In addition to MK-2870 and paclitaxel, the study may involve other medications such as buclizine hydrochloride, paracetamol (also known as acetaminophen), codeine phosphate, ramucirumab, and glucocorticoids. These medications may be used to manage symptoms or side effects. The study aims to provide valuable information on the potential benefits and risks of these combination therapies for patients with advanced gastroesophageal cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment begins

    After you join the study, you start one of the assigned treatment combinations for advanced gastroesophageal adenocarcinoma (a cancer of the area where the food pipe meets the stomach, or the stomach itself). The study is open-label, which means that the treatment given is known and is not hidden.

    The study includes different treatment groups. The listed medicines are paclitaxel given by intravenous infusion (medicine given into a vein), ramucirumab given by intravenous infusion, MK-2870 (sacituzumab tirumotecan) given as a solution for injection, and MK-1022 (patritumab deruxtecan) given as a solution for intravenous infusion.

    Some medicines are also listed as background treatment: glucocorticoids (a type of steroid medicine), an H2-receptor antagonist (a medicine that reduces stomach acid), antihistamines (medicine used to reduce allergic reactions), and paracetamol taken by mouth. The source data do not give the dose, frequency, or duration for these medicines.

  2. Step 2

    Safety lead-in phase

    During the safety lead-in phase, your treatment is checked for safety and tolerability. This means the study team looks for side effects and decides whether the treatment combination can be given safely.

    The main safety measures are whether you develop a dose-limiting toxicity (a side effect severe enough to limit treatment), whether you have any adverse event (a medical problem that happens during the study), and whether you stop the study treatment because of an adverse event.

    No dose, frequency, or exact treatment length is provided in the source data for the medicines used in this phase.

  3. Step 3

    Efficacy phase

    If you continue in the study, the next part checks how well the treatment works. The study measures the objective response rate (ORR), which means the percentage of participants whose cancer gets smaller or disappears on scans.

    The study also measures progression-free survival (PFS), which is the time during which the cancer does not get worse; duration of response (DOR), which is how long a response lasts; and overall survival (OS), which is how long participants live after starting treatment.

    During this phase, the study also records the percentage of participants who have an adverse event or stop study treatment because of an adverse event. The source data do not provide the dose, frequency, or duration of the medicines.

  4. Step 4

    Antibody testing and follow-up assessments

    The study checks for anti-drug antibodies (ADAs), which are proteins your body may make against a study medicine. This is listed for sacituzumab tirumotecan and patritumab deruxtecan.

    The study period continues with assessment of safety and cancer response through the trial stages. The source data do not provide any additional trial steps, medication schedules, or exact treatment duration beyond the overall study dates.

Who can join the trial?

11 criteria

  • Have a confirmed diagnosis by tissue or cell testing of one of the following: stomach adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma that has been treated before and is now in the second line of treatment, meaning it has already received a first treatment and needs another one.
  • Have metastatic disease, meaning the cancer has spread, or locally advanced, unresectable disease, meaning the cancer has grown too much to be removed by surgery.
  • Have clear proof that the cancer got worse, seen on scans or by medical examination, during or after first-line treatment that included a platinum drug and a fluoropyrimidine, with or without immunotherapy (treatment that helps the immune system fight cancer).
  • Have tumor tissue that is HER2 negative, meaning the tumor does not show too much of the HER2 protein, based on approved testing rules.
  • Be able to provide a core biopsy or excisional biopsy, meaning a sample taken from a tumor, from a tumor area that has not been treated with radiation, and the sample must be taken after the most recent cancer treatment.
  • Have side effects from previous cancer treatments that are Grade 1 or better, meaning mild or back to the person’s usual level, except for hair loss and vitiligo (loss of skin color in patches). Endocrine-related side effects, meaning problems with hormone-producing glands, are allowed if they are well controlled with hormone replacement.
  • Have an ECOG performance status of 0 or 1, meaning the person is fully active or only slightly limited in daily activities.
  • Have an expected life span of at least 3 months.
  • If there is a history of hepatitis B, have received antiviral treatment for at least 4 weeks and have an undetectable viral load, meaning the virus is not found in the blood before joining the study.
  • If there is a history of hepatitis C, have an undetectable viral load at screening, meaning the virus is not found in the blood when first checked for the study.
  • If living with HIV, have the infection well controlled with ART (antiretroviral therapy, medicine that lowers the HIV amount in the body).

Who cannot join the trial?

30 criteria

  • The cancer must not be a squamous cell or undifferentiated gastroesophageal cancer.
  • Blood pressure must not be uncontrolled, meaning it is at or above 150/90 mm Hg.
  • There must not be fluid buildup around the lungs, in the abdomen, or around the heart that needed drainage or water pills within the past 2 weeks.
  • The patient must not have had major surgery within the past 28 days, a central venous access device placed within the past 7 days, or planned major surgery after starting study treatment. A central venous access device is a tube placed into a large vein to give medicines or fluids.
  • The patient must not be receiving therapeutic anticoagulation such as warfarin, low-molecular-weight heparin, or similar blood-thinning medicines used to prevent clots.
  • The patient must not be taking long-term nonsteroidal anti-inflammatory drugs or other antiplatelet medicines. These are medicines that can increase bleeding risk.
  • The patient must not have had deep vein thrombosis, pulmonary embolism, or another major blood clot problem within the past 3 months. Deep vein thrombosis is a clot in a deep vein, usually in the leg. Pulmonary embolism is a clot in the lung.
  • The patient must not have important bleeding disorders, vasculitis (inflammation of blood vessels), or a significant bleeding episode from the digestive tract within the past 3 months.
  • The patient must not have a history of gastrointestinal perforation or fistula within the past 6 months. A perforation is a hole in the digestive tract. A fistula is an abnormal connection between body parts.
  • A person with HIV must not have a history of Kaposi’s sarcoma or Multicentric Castleman’s Disease.
  • The patient must not have previously received a treatment that targets TROP2 or HER3, a topoisomerase 1 inhibitor-based ADC, a topoisomerase 1 inhibitor-based chemotherapy, or any past systemic treatment that targets the VEGF or VEGFR pathways. An ADC is an antibody-drug conjugate, a type of medicine that carries a drug to cancer cells.
  • The patient must not have lost more than 20% of body weight in the 3 months before the first study dose.
  • The patient must not have received other systemic anticancer therapy within 4 weeks before the first study dose. Systemic treatment is treatment that travels through the whole body.
  • The patient must not have received radiotherapy within 2 weeks before starting study treatment, and must not have radiation side effects that need corticosteroids. Radiotherapy is treatment with radiation.
  • The patient must not have received a live vaccine or live-attenuated vaccine within 30 days before the first study dose. Killed vaccines are allowed.
  • The patient must not have received another investigational agent or used an investigational device within 4 weeks before study treatment. Investigational means not yet approved for general use.
  • The patient must not have another cancer that is growing or has needed active treatment within the past 3 years, except for certain skin cancers and some early cancers that were completely treated.
  • The patient must not have active central nervous system metastases or carcinomatous meningitis. Central nervous system metastases are cancer spread to the brain or spinal cord. Carcinomatous meningitis is cancer involving the lining around the brain and spinal cord.
  • The patient must not have an active infection that needs treatment through the whole body.
  • The patient must not have active hepatitis B or hepatitis C infection. These are viral infections of the liver.
  • The patient must not have pneumonitis or interstitial lung disease, and it must not be unclear on screening scans whether these lung problems are present. Pneumonitis is inflammation of the lungs, and interstitial lung disease is scarring or inflammation in the lung tissue.
  • The patient must not have a severe allergy reaction, called grade 3 or higher hypersensitivity, to MK-2870, HER3-DXd, any of their ingredients, or another biologic therapy. Biologic therapy is treatment made from living sources or living cells.
  • The patient must not have had documented severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or severe corneal disease that could slow healing of the cornea. The cornea is the clear front part of the eye.
  • The patient must not have fully recovered from major surgery or have ongoing problems from surgery.
  • The patient must not have grade 2 or higher peripheral neuropathy. Peripheral neuropathy means nerve damage that can cause numbness, tingling, or pain in the hands or feet.
  • The patient must not have active inflammatory bowel disease that needs medicines that suppress the immune system, and must not have a past history of inflammatory bowel disease. Inflammatory bowel disease includes long-term inflammation of the intestines.
  • The patient must not have a serious or nonhealing wound, a peptic ulcer, or a bone fracture within 28 days before allocation/randomization. A peptic ulcer is a sore in the stomach or upper intestine.
  • The patient must not have a bowel obstruction, a history of inflammatory enteropathy, or extensive removal of the intestine with chronic diarrhea. Bowel obstruction means a blockage in the intestine, and inflammatory enteropathy means inflammation of the intestines.
  • The patient must not have uncontrolled, significant heart disease or blood vessel disease, or significant cerebrovascular disease, which means disease of the blood vessels in the brain.
  • The patient must not have had a major arterial blood clot event within 6 months, including heart attack, unstable angina (new or worsening chest pain), stroke, or transient ischemic attack (a temporary stroke-like episode).
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Paclitaxel

    is a chemotherapy medicine given through a vein. In this trial, it is part of the standard treatment used to help slow or stop the growth of cancer cells.

  • MK-2870

    is an investigational cancer medicine. It is being tested to see whether it can safely and effectively treat advanced stomach or gastroesophageal cancer, especially when combined with standard treatment.

  • Patritumab deruxtecan

    is another investigational cancer medicine given through a vein. It is designed to target cancer cells more directly and is being studied to see how well it works and how safe it is in this cancer setting.

  • Ramucirumab

    is a cancer treatment given through a vein. It works by blocking signals that help tumors grow new blood vessels, which may help slow the cancer’s growth.

  • Paracetamol

    is a pain-relief medicine taken by mouth. In this trial, it is used as supportive care to help reduce pain or discomfort related to treatment.

  • Glucocorticoids

    are steroid medicines used as supportive care. They may help lower inflammation and reduce side effects from cancer treatment, such as allergic-type reactions or nausea.

What is already known about the treatment

  • Paclitaxel

    Paclitaxel is given by intravenous infusion, which means it is delivered slowly into a vein by a healthcare professional. It is a well-known cancer medicine that is widely used in medical practice and strongly described in medical literature. It is used to treat several cancers, including gastroesophageal cancer, and it works by blocking cancer cells from dividing normally, which slows or stops tumor growth. It belongs to the group of anticancer medicines called taxanes, or microtubule inhibitors.

  • Sacituzumab tirumotecan

    Sacituzumab tirumotecan is given as an injection, usually through a vein by a trained healthcare provider. It is an investigational cancer medicine, meaning it is still being studied and is not yet widely established in routine medical care, although it is discussed in current medical research. It is designed to treat certain cancers by carrying a cell-killing drug directly to cancer cells and helping deliver it inside the cell, which can damage the cell’s DNA and lead to cell death. It belongs to a newer group of targeted anticancer medicines called antibody-drug conjugates.

  • Patritumab deruxtecan

    Patritumab deruxtecan is given as a powder that is mixed into a solution and then infused into a vein by a healthcare professional. It is an investigational medicine that is still being studied in clinical trials and is not yet a standard treatment in routine care, though it is increasingly described in medical literature. It is being developed for some cancers, including advanced cancers, and it works by attaching to a cancer cell marker and carrying a strong anticancer drug into the cell, where it can damage the cell’s DNA and cause the cell to die. It is classified as an antibody-drug conjugate, a type of targeted cancer treatment.

  • Ramucirumab

    Ramucirumab is given by intravenous infusion, meaning it is infused into a vein under medical supervision. It is an approved medicine and is well established in cancer treatment and medical literature. It is used to treat several advanced cancers, including gastroesophageal cancer, and it works by blocking a signal that tumors need to make new blood vessels, which helps slow tumor growth. It belongs to the group of targeted anticancer medicines known as monoclonal antibodies.

  • Paracetamol

    Paracetamol is taken by mouth as an oral medicine. It is a very common and well-known medicine that is widely used in everyday medical care and is strongly supported by medical literature. It is mainly used to reduce pain and fever, and in this trial it is part of supportive care rather than a cancer treatment. It is classified as an analgesic and fever-reducing medicine, and it works by lowering the body’s pain and fever signals in the brain.

Investigated diseases

Gastroesophageal cancer - Gastroesophageal cancer is a cancer that starts in the area where the esophagus meets the stomach. It usually grows by invading nearby tissue and can spread to lymph nodes and other parts of the body. As it progresses, it may cause narrowing of the passage for food and affect normal swallowing and digestion.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509306-29-00Protocol codeMK-3475-06DEstimated enrolment210 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).