A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors
NCT ID: NCT06431594
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
385 participants
INTERVENTIONAL
2024-07-02
2027-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
Participants with advanced solid tumors who are refractory or intolerant to established standard therapies
GSK5733584
GSK5733584 will be administered
Part 2: Dose Expansion
Participants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)
GSK5733584
GSK5733584 will be administered
Interventions
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GSK5733584
GSK5733584 will be administered
Eligibility Criteria
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Inclusion Criteria
* Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care).
* PROC cohort
1. Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
2. Must have received or are intolerant to 1 but no more than 3 lines of prior systemic therapy.
3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.
4. Must have had prior bevacizumab if the participant was considered a candidate for this regimen and the regimen is locally available.
5. Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtasine if the participants was considered a candidate for this regimen and the regimen is locally available.
6. Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the participant was considered a candidate for this regimen and the regimen is locally available.
* Endometrial cancer cohort
1. Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer.
2. Must have received or are intolerant to 1 but no more than 3 lines of prior systemic therapy.
3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if considered a candidate for this regimen and the regimen is locally available.
4. All epithelial histologies are permitted including carcinosarcoma.
* Participants have at least one target lesion as assessed per the RECIST 1.1
* Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.
* Have a life expectancy of at least 12 weeks.
Exclusion Criteria
* Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.
* Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
* Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
* Major surgery within 28 days prior to the first dose of study treatment.
* Evidence of brain metastasis unless asymptomatic.
* Has inadequate bone marrow reserve or hepatic/renal functions.
* Mean Fridericia-corrected QT interval (QTcF) \> 470 millisecond (msec) on resting ECG.
* Evidence of current clinically significant arrhythmias or ECG abnormalities
* Risk factors of prolonged QTc or arrhythmia events,
* Left ventricular ejection fraction (LVEF) \< 50%.
* Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
* Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.
* Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)
* PROC
1. Primary platinum refractory disease defined as those who have progressed on or within 12 weeks of last dose of first line platinum therapy not permitted.
2. Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted.
* Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Lake Mary, Florida, United States
GSK Investigational Site
Fairway, Kansas, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Grand Rapids, Michigan, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
West Valley City, Utah, United States
GSK Investigational Site
Cipoletti Rio Negro, , Argentina
GSK Investigational Site
Ciudad de Buenos Aires, , Argentina
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
Blacktown, New South Wales, Australia
GSK Investigational Site
Macquarie University, New South Wales, Australia
GSK Investigational Site
Leuven, , Belgium
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Helsinki, , Finland
GSK Investigational Site
Tampere, , Finland
GSK Investigational Site
Lyon, , France
GSK Investigational Site
Saint-Herblain, , France
GSK Investigational Site
Villejuif, , France
GSK Investigational Site
Roma, , Italy
GSK Investigational Site
Rozzano MI, , Italy
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Shizuoka, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Amsterdam, , Netherlands
GSK Investigational Site
Gyeonggi-do, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Córdoba, , Spain
GSK Investigational Site
Girona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, , Spain
GSK Investigational Site
Stockholm, , Sweden
GSK Investigational Site
Uppsala, , Sweden
GSK Investigational Site
Cambridge, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-513860-25
Identifier Type: REGISTRY
Identifier Source: secondary_id
222730
Identifier Type: -
Identifier Source: org_study_id
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