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Study on the Safety and Effectiveness of GSK5733584 with Dostarlimab and Carboplatin for Patients with Advanced Gynecological Tumors

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying advanced solid tumors, which are a type of cancer that forms in the body's tissues. The study will explore the effects of a new treatment called GSK5733584, which will be used in combination with other anti-cancer medications. These medications include Jemperli (also known as dostarlimab), Carboplatin, Cisplatin, and Avastin (also known as bevacizumab). The purpose of the study is to determine the safety and effectiveness of these combinations in treating advanced solid tumors.

The study will be conducted in two parts. In the first part, the focus will be on finding the right dose of GSK5733584 when used with the other medications. This will help establish the recommended dose for future studies. In the second part, the study will evaluate how well the combination treatments work compared to using GSK5733584 alone. Participants will receive the treatments through an intravenous infusion, which means the medication will be given directly into a vein.

Throughout the study, researchers will monitor participants for any side effects and measure how the cancer responds to the treatment. The study aims to provide valuable information on the potential benefits of combining GSK5733584 with other anti-cancer drugs for people with advanced solid tumors. The study is expected to continue until 2028, with recruitment starting in 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be informed about the trial's purpose, procedures, and potential risks and benefits. Participants will be required to sign an informed consent form, confirming their understanding and willingness to participate.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes providing a sample of tumor tissue for analysis and undergoing various tests to assess overall health and organ function.

  3. Step 3

    Treatment phase part a

    In Part A, participants will receive a combination of the study drug GSK5733584 with other anti-cancer medications such as dostarlimab, carboplatin, cisplatin, and bevacizumab. All medications will be administered through an intravenous infusion, which means they will be given directly into a vein.

    The dosage and frequency of administration will be determined based on safety and tolerability. Participants will be closely monitored for any side effects or adverse reactions.

  4. Step 4

    Treatment phase part b

    In Part B, the focus will be on evaluating the effectiveness of the study drug GSK5733584 in combination with other treatments compared to using GSK5733584 alone. Participants will continue to receive medications through intravenous infusion.

    The duration of this phase will depend on the participant's response to the treatment and any side effects experienced.

  5. Step 5

    Regular monitoring

    Throughout the trial, participants will have regular check-ups to monitor their health and the effects of the treatment. This includes blood tests, imaging scans, and assessments of any symptoms or side effects.

    Participants will be required to report any new symptoms or changes in their condition to the study team promptly.

  6. Step 6

    End of treatment

    At the end of the treatment period, participants will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

    Participants will be informed about the next steps, including any follow-up care or additional treatments that may be necessary.

Who can join the trial?

8 criteria

  • Participants must be 18 years of age or older at the time of signing the consent form.
  • Participants must have a confirmed advanced solid tumor, which means a type of cancer that forms in body tissues. They should have tried standard treatments that did not work, or they cannot tolerate them, and should not have had more than four different treatments before.
  • Participants need to provide a sample of their tumor tissue. This can be an old sample from a previous procedure or a new sample if an old one is not available. This is to check for specific markers in the tumor.
  • Participants must have at least one measurable tumor that has not been treated with local therapies like radiation, or if it was treated, it must have clearly grown back. The tumor should be at least 10 mm in size.
  • Participants should have a life expectancy of at least 12 weeks.
  • Participants must agree to use effective birth control methods during the study.
  • Participants should have an ECOG performance status of 0 to 1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
  • Participants must have normal function of their organs and bone marrow, which is the soft tissue inside bones where blood cells are made.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer besides gynecological tumors cannot participate.
  • Patients who have not recovered from previous cancer treatments or surgeries are excluded.
  • Patients with severe heart problems or uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, including HIV or hepatitis, are not eligible. HIV is a virus that affects the immune system, and hepatitis is an inflammation of the liver.
  • Pregnant or breastfeeding women cannot participate.
  • Patients who have participated in another clinical trial within the last 4 weeks are excluded.
  • Patients with known allergies to the study drugs or similar drugs cannot join.
  • Patients with a history of drug or alcohol abuse in the past 6 months are not eligible.
  • Patients with any other serious medical condition that might interfere with the study are excluded.
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Investigated drugs

GSK5733584 is a new medication being tested to see how safe and tolerable it is for people with advanced solid tumors. This medication is being studied to find out how well it works when used alone and when combined with other cancer treatments. The goal is to determine the best dose to use in future studies and to see if it can help fight cancer more effectively.

What is already known about the treatment

GSK5733584 – This medication is administered in combination with other anti-cancer agents to treat advanced solid tumors, specifically gynecological tumors. It is currently being studied in clinical trials to assess its safety, tolerability, and effectiveness. The main goal is to find the best dose that can be used safely with other treatments. GSK5733584 works by targeting specific molecules in cancer cells, helping to stop their growth and spread. It is classified as an anti-cancer drug, and researchers are exploring its potential to improve outcomes for patients with advanced cancer.

Investigated diseases

Gynecological Tumors – Gynecological tumors refer to abnormal growths that develop in the female reproductive system, including the ovaries, uterus, cervix, and other related structures. These tumors can be benign or malignant, with malignant tumors having the potential to invade nearby tissues and spread to other parts of the body. The progression of gynecological tumors varies depending on the type and location of the tumor. Some tumors may grow slowly and remain localized, while others can grow rapidly and metastasize. Symptoms may include abnormal bleeding, pelvic pain, and changes in menstrual cycles. The progression and impact of these tumors depend on various factors, including the specific type of tumor and the stage at which it is detected.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517147-31-00Protocol code223559Estimated enrolment305 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

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