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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
MD Anderson Cancer Center Madrid Spain
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Biokinetica S.A. Jozefow Poland
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Karolinska University Hospital Solna Sweden
Hospital Hm Nou Delfos Barcelona Spain
St. Luke’s Hospital S.A. Thessaloniki Greece
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Lux Med Onkologia Sp. z o.o. Warsaw Poland
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Virgen De La Victoria Malaga Spain
Cgufpceul Uypivsmiuwaphb Sxnqeetvz Woluwe-Saint-Lambert Belgium
Ijfwuofx Rxkkiyrk Df Cktiwt Dp Mjwlesujnyw Montpellier France
Hhawrnxtb Mlcvdaob Shujkc Milan Italy
Cptkjl Lvvw Bmtbex Lyon France
Utwegcltpo Hjfzlflb Cidrqbl Aqn Cologne Germany
Hulghm Herhmtrr Herlev Denmark
Axsuwzvgt Udx Amsterdam The Netherlands
Hrnjgtau Uberymfqxi Coyxino Hpclgdom Helsinki Finland
Ejfjxrs Uhdyphwbtylg Mypnlje Cwilkca Rycnnsmfm (hzxtbdl Mns Rotterdam The Netherlands
Aedahq Msjkhzs Cmgfhq Ssgq Thessaloniki Greece
Nqeulaty Ibosbpdj Olhwxjlkn Icn Manyp Svdrtdxrhivbcvgjewsktmtmlsov Inbrjsuk Bwveuewc Cracow Poland
Kbhsettf dki Urpsdudcjgbe Mcztgdbm Avu Munich Germany
Hyarikpa Vaml dlocdyok Barcelona Spain
Ifyyguud Pdzaywifkrwtere Cwzpln Clztkz Marseille France
Hscmpjkk Uhmpgusbhdloe dk A Cpqupw A Coruna Galicia Spain
Upqucleqnl Gbgxiwo Hvbaaeiy Ajjqkro Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
13.05.2025
Denmark Denmark
Recruiting
13.05.2025
Finland Finland
Recruiting
13.05.2025
France France
Recruiting
13.05.2025
Germany Germany
Recruiting
13.05.2025
Greece Greece
Recruiting
13.05.2025
Italy Italy
Recruiting
13.05.2025
Norway Norway
Recruiting
13.05.2025
Poland Poland
Recruiting
13.05.2025
Spain Spain
Recruiting
13.05.2025
Sweden Sweden
Recruiting
13.05.2025
The Netherlands The Netherlands
Recruiting
13.05.2025

Trial locations

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.

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 ID:
2024-517147-31-00
Protocol code:
223559
NCT ID:
NCT06796907
Trial Phase:
Human Pharmacology (Phase I) – Other

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