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Study of GSK5764227 Safety and Efficacy in Adults with Previously Treated Advanced Unresectable or Metastatic Sarcoma

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What is this trial about?

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

The study focuses on people with advanced Sarcoma, a rare cancer that begins in the body’s connective tissues. Two specific forms are included: Osteosarcoma, which starts in bone, and Soft tissue sarcoma, which begins in muscle, fat, or other soft tissues. The investigational medication being tested is Risvutatug Rezetecan (code name GSK5764227), which is given by an IV infusion, meaning it is delivered directly into a vein. The term “unresectable” means the tumor cannot be removed by surgery, “metastatic” means the cancer has spread to other parts of the body, and “relapsed/refractory” describes cancer that has returned or did not respond to earlier treatments.

The purpose of the study is to evaluate the efficacy and safety of the drug in participants whose disease has progressed after at least one prior line of systemic therapy. Participants will receive the medication in a series of treatment visits over several months, with regular check‑ups to see how the cancer is responding and to monitor any side effects. The study will continue until a predetermined follow‑up period is completed.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining, you will undergo a series of baseline tests that include a physical examination, blood tests, and imaging scans. these evaluations establish your health status before treatment begins.

  2. Step 2

    First infusion of <b>gsk5764227</b>

    You will receive the study medication as an intravenous infusion. the medication is supplied as a powder for solution for infusion and is administered through a vein. the exact dose and infusion time are defined by the study protocol.

  3. Step 3

    Subsequent infusions

    You will continue to receive additional infusions of gsk5764227 according to the schedule set by the protocol. infusions are repeated at regular intervals until disease progression, unacceptable side effects, or completion of the planned treatment course.

  4. Step 4

    Regular safety visits

    Between infusions, you will attend clinic visits for safety monitoring. these visits include blood tests, physical examinations, and review of any symptoms you may experience.

  5. Step 5

    Efficacy assessment at <b>week 18</b>

    Approximately eighteen weeks after the first infusion, you will undergo imaging scans to evaluate tumor response. the primary measure at this time is progression free survival, which determines whether the disease has remained stable or improved.

  6. Step 6

    End‑of‑treatment evaluation

    When treatment is discontinued, you will have a final assessment that includes the same tests performed at baseline and during the study. this evaluation documents the overall outcome of the therapy.

  7. Step 7

    Post‑treatment follow‑up

    After the end of treatment, you will continue to be monitored at scheduled intervals. follow‑up visits focus on long‑term safety and any delayed effects of the study medication.

Who can join the trial?

6 criteria

  • Be at least 12 years old (12 years or older).
  • Have a diagnosis that is histologically confirmed (checked under a microscope) of a sarcoma that is unresectable (cannot be removed by surgery), is advanced or metastatic (has spread to other parts of the body), and is either osteosarcoma (bone cancer) or soft‑tissue sarcoma that has come back or not responded after at least one previous systemic therapy (medicine that travels through the whole body).
  • Show that the cancer has gotten worse on the most recent treatment, proven by radiological imaging (a scan such as X‑ray, CT or MRI).
  • Have a good overall health rating: an ECOG performance status of 0 or 1 (fully active or able to do light work) or, for younger participants, a Lansky/Karnofsky performance status of 70 % or higher (able to take care of most daily activities), with no decline in the two weeks before the first dose.
  • Have adequate organ function (liver, kidneys, blood, heart and other major organs working well) as shown by laboratory tests.
  • Provide signed informed consent (a written agreement by you or your legal guardian) and agree to follow the study rules before any study activities start.

Who cannot join the trial?

7 criteria

  • Antibody‑drug conjugate (ADC) with a TOPO1‑inhibitor payload – you have already been treated with a special type of medicine that attaches a chemotherapy drug to an antibody and contains a drug that blocks an enzyme needed for DNA.
  • Allergy (sensitivity) to study drug components or excipients – you are known to be allergic to any ingredient in the study medication or to other substances that the investigators think make participation unsafe.
  • Severe, uncontrolled or active cardiovascular disorders – you have serious heart or blood‑vessel problems that are not well controlled.
  • Active infectious diseases requiring systemic treatment or known HIV – you have an ongoing infection that needs medication that works throughout the whole body, or you are known to have HIV.
  • Symptomatic brain or spinal cord metastases – cancer that has spread to the brain or spinal cord and is causing symptoms, or untreated growth of cancer in those areas, including involvement of the brain’s lining (leptomeningeal) or brainstem.
  • Recent treatment with an investigational agent – you have taken another experimental drug within the four weeks before the first dose of the study medication.
  • Pregnancy or breastfeeding – you are currently pregnant or are feeding a baby with breast milk.
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Investigated drugs

GSK5764227 is an experimental medicine being studied to see if it can help people with certain advanced or metastatic sarcomas that have returned after previous treatments. In the trial the drug is given through a vein (intravenous) as a powder that is mixed with liquid to make an infusion. Researchers are looking at how well it works and whether it is safe for patients.

What is already known about the treatment

GSK5764227 - This drug is given by intravenous infusion, supplied as a powder that is mixed with liquid before use. It is currently an investigational medicine being studied in early clinical trials for rare sarcoma cancers. The drug is designed to block a protein that helps tumor cells grow and survive, slowing the spread of the disease. It belongs to the class of targeted anticancer agents.

Investigated diseases

  • Osteosarcoma

    A bone cancer that starts in the cells that make bone, most often affecting the long bones near the knee or shoulder. It can grow rapidly and may spread to other parts of the body, especially the lungs. When it cannot be removed surgically, the tumor may continue to enlarge despite prior medicines.

  • Soft tissue sarcoma

    A group of cancers that arise in the connective tissues such as muscle, fat, nerves, or blood vessels. These tumors can increase in size and may spread locally or to distant organs. In advanced stages, they can keep growing even after earlier treatments.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523997-18-00Protocol code300640Estimated enrolment68 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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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).