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GSK5733584 for Platinum-resistant Ovarian Cancer

Study Aim

This study aims to evaluate the effectiveness of GSK5733584 in improving overall survival and progression-free survival in individuals with platinum-resistant ovarian cancer.

What is being tested

GSK5733584

+ Paclitaxel

+ Pegylated liposomal doxorubicin (PLD)

Drug

Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: June 2026

See protocol details

Summary

Principal SponsorGlaxoSmithKline

Study ContactUS GSK Clinical Trials Call CenterMore contacts

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 24, 2026

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new drug, GSK5733584, to see how it compares to the usual chemotherapy treatments in women with ovarian cancer that does not respond to standard platinum-based therapies. This type of ovarian cancer is known as platinum-resistant. The study is important because finding effective treatments for this group of patients is challenging, and new options could improve survival and quality of life. Researchers are also looking at how well patients tolerate GSK5733584 and what side effects it may have, compared to traditional chemotherapy. Participants in this study will either receive the new drug, GSK5733584, or the usual chemotherapy treatment. The drug will be given in a way determined by the study doctors, which is not specified in detail here. The main things the study will measure are how long patients live (overall survival) and how long they live without the cancer getting worse (progression-free survival). This information will be gathered by monitoring patients from the start of their treatment until the study ends. The study will also carefully track any side effects to ensure that the treatment is safe and manageable for patients.

Official TitleA Randomized, Open-label, Multicenter, Phase 3 Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer

NCT07286266

Principal SponsorGlaxoSmithKline

Study ContactUS GSK Clinical Trials Call CenterMore contacts

Last updated: March 20, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

450 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

12 inclusion criteria required to participate

Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF).

Has epithelial ovarian, primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, or clear cell carcinoma, or carcinosarcoma that is resistant to platinum-based therapy.

Has received at least 1 but no more than 3 prior lines of systemic anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment. Participants who received mirvetuximab soravtansine as prior therapy are permitted to have received up to 4 prior lines. Prior lines of therapy are defined as follows: * Adjuvant ± neoadjuvant are considered one line of therapy. * Maintenance therapy (e.g., bevacizumab, \[Poly adenosine diphosphate-ribosylation (ADP) ribose polymerase inhibitor (PARPi)\] will be considered as part of the preceding line of therapy (i.e., not counted independently). * Therapy changed to another agent in the same class due to toxicity in the absence of progression will be considered as part of the same line (i.e., not counted independently). * Unplanned addition or switching to a new drug in a different class is considered a separate line of therapy. * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance.

Has adequate organ function

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16 exclusion criteria prevent from participating

Has received treatment with any cytotoxic chemotherapy drugs or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy, or investigational agent) within 30 days or 5 half-lives, whichever is shorter, prior to date of C1D1; or need to continue these drugs during study participation.

Has received any live vaccine within 30 days prior to date of C1D1.

Use of drugs known to prolong the QT interval or potentially cause torsades de pointes; or need to continue these medications during the study and up to 30 days after the last dose of study intervention.

Has received treatment with strong or moderate inhibitor of Cytochrome P450 3A4 (CYP3A4) or Cytochrome P450 2D6 (CYP2D6), strong or moderate inducer of CYP3A4, inhibitor of P-glycoprotein (P-gp) or Breast cancer resistant protein (BCRP), or inducer of P-gp within 14 days prior to date of C1D1 or anticipates their use during study participation and up to 30 days after the last dose of study intervention administration.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive GSK5733584

Group II

Active Comparator

Participants will receive standard of care chemotherapy (Paclitaxel or PLD or Topotecan or Gemcitabine) as per investigator's choice

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers