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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors
Led by GlaxoSmithKline · Updated on 2025-06-25
385
Participants Needed
47
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older (≥18 years)
- Participants with pathologically confirmed advanced solid tumor who have failed or are intolerant to standard of care
- Histologically documented advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer for PROC cohort
- Received or intolerant to 1 to 3 lines of prior systemic therapy
- Platinum-resistant disease defined as progression or relapse within 6 months after platinum-based therapy
- Prior bevacizumab if considered a candidate and locally available
- Known Folate receptor-α expressing tumors must have received mirvetuximab soravtasine if candidate and locally available
- Known BRCA mutated tumors should have received a PARP inhibitor if candidate and locally available
- Histologically documented advanced or recurrent endometrial cancer for endometrial cancer cohort
- Received or intolerant to 1 to 3 lines of prior systemic therapy
- Prior platinum and PD(L)-1 inhibitor if candidate and locally available
- All epithelial histologies including carcinosarcoma permitted
- At least one target lesion per RECIST 1.1
- Tumor tissue from new biopsy or archival tissue within 2 years prior to first dose for biomarker analysis
- ECOG Performance Status of 0 to 2 with no deterioration within 2 weeks before first dose
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Received any B7-H4-targeted therapies
- Received cytotoxic chemotherapy, anti-tumor traditional Chinese medicines, or other anti-tumor drugs within 28 days prior to first dose or need to continue during study
- Received locoregional radiation therapy within 2 weeks prior to first dose
- More than 30% bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to first dose
- Presence of pleural or abdominal effusion or ascites requiring intervention; presence of pericardial effusion
- Major surgery within 28 days prior to first dose
- Evidence of brain metastasis unless asymptomatic
- Inadequate bone marrow reserve or hepatic/renal functions
- Mean QTcF > 470 msec on resting ECG
- Current clinically significant arrhythmias or ECG abnormalities
- Risk factors for prolonged QTc or arrhythmia events
- Left ventricular ejection fraction < 50%
- Severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms, or serious thromboembolic events
- Current or prior interstitial lung disease or pneumonitis requiring high-dose systemic glucocorticoids
- Prior therapy with topoisomerase inhibitors or topoisomerase inhibitor antibody-drug conjugates
- For PROC cohort: primary platinum refractory disease (progression within 12 weeks of first line platinum therapy) not permitted
- Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted
- For endometrial cancer: mesenchymal tumors of the uterus (uterine sarcomas) not permitted
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
GSK Investigational Site
Lake Mary, Florida, United States, 32746
Actively Recruiting
2
GSK Investigational Site
Fairway, Kansas, United States, 66205
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3
GSK Investigational Site
Boston, Massachusetts, United States, 02114
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4
GSK Investigational Site
Boston, Massachusetts, United States, 02215
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5
GSK Investigational Site
Detroit, Michigan, United States, 48201
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6
GSK Investigational Site
Grand Rapids, Michigan, United States, 49546
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7
GSK Investigational Site
Nashville, Tennessee, United States, 37203
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8
GSK Investigational Site
Dallas, Texas, United States, 75230
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9
GSK Investigational Site
West Valley City, Utah, United States, 84119
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10
GSK Investigational Site
Cipoletti Rio Negro, Argentina, R8324CVE
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11
GSK Investigational Site
Ciudad de Buenos Aires, Argentina, 1118
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12
GSK Investigational Site
Rosario, Argentina, S2002
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13
GSK Investigational Site
Blacktown, New South Wales, Australia, 2148
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14
GSK Investigational Site
Macquarie University, New South Wales, Australia, 2109
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15
GSK Investigational Site
Leuven, Belgium, 3000
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16
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
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17
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
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18
GSK Investigational Site
Montreal, Quebec, Canada, H2X 0A9
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19
GSK Investigational Site
Helsinki, Finland, 00180
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20
GSK Investigational Site
Helsinki, Finland, 00290
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21
GSK Investigational Site
Tampere, Finland, 33520
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22
GSK Investigational Site
Lyon, France, 69373
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23
GSK Investigational Site
Saint-Herblain, France, 44805
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24
GSK Investigational Site
Villejuif, France, 94805
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25
GSK Investigational Site
Roma, Italy, 00168
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26
GSK Investigational Site
Rozzano MI, Italy, 20089
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27
GSK Investigational Site
Saitama, Japan, 350-1298
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28
GSK Investigational Site
Shizuoka, Japan, 411-8777
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29
GSK Investigational Site
Tokyo, Japan, 135-8550
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30
GSK Investigational Site
Amsterdam, Netherlands, 1066 CX
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31
GSK Investigational Site
Gyeonggi-do, South Korea, 10408
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32
GSK Investigational Site
Seoul, South Korea, 03080
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33
GSK Investigational Site
Seoul, South Korea, 03722
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34
GSK Investigational Site
Seoul, South Korea, 06351
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35
GSK Investigational Site
Barcelona, Spain, 08035
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36
GSK Investigational Site
Córdoba, Spain, 14004
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37
GSK Investigational Site
Girona, Spain, 17007
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38
GSK Investigational Site
Madrid, Spain, 28027
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39
GSK Investigational Site
Madrid, Spain, 28034
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40
GSK Investigational Site
Madrid, Spain, 28040
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41
GSK Investigational Site
Madrid, Spain, 28046
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42
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain, 28223
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43
GSK Investigational Site
Stockholm, Sweden, 17164
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44
GSK Investigational Site
Uppsala, Sweden, SE-751 85
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45
GSK Investigational Site
Cambridge, United Kingdom, CB2 0QQ
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46
GSK Investigational Site
London, United Kingdom, NW1 2PG
Actively Recruiting
47
GSK Investigational Site
London, United Kingdom, W1G 6AD
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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