Phase
Condition
Solid Tumors
Neoplasms
Treatment
GSK5733584
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females aged 18 years or older (≥18 years).
Participants with pathologically confirmed advanced solid tumor (who have failed orare intolerant to standard of care).
PROC cohort
Histologically documented, advanced (metastatic and/or unresectable) high-gradeserous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
Must have received or are intolerant to 1 but no more than 3 lines of priorsystemic therapy.
Platinum-resistant disease, defined as progression or relapse within 6 monthsafter the completion of platinum-based therapy.
Must have had prior bevacizumab if the participant was considered a candidatefor this regimen and the regimen is locally available.
Participants with known Folate receptor-α (FR-α) expressing tumors must havereceived mirvetuximab soravtasine if the participants was considered acandidate for this regimen and the regimen is locally available.
Participants with known Breast cancer susceptibility gene (BRCA) mutated tumorsshould have received a Poly adenosine diphosphate-ribose polymerase (PARP)inhibitor if the participant was considered a candidate for this regimen andthe regimen is locally available.
Maintenance therapy will be considered part of the preceding line of therapy (ie, not counted independently).
- Endometrial cancer cohort
Histologically documented, advanced (metastatic and/or unresectable) orrecurrent endometrial cancer.
Must have received or are intolerant to 1 but no more than 2 lines of priorsystemic therapy.
Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or inseparate regimens), if considered a candidate for this regimen and the regimenis locally available.
Maintenance therapy will be considered part of the preceding line of therapy (ie, not counted independently
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 forretrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newlyobtained biopsy is preferred. If a newly obtained biopsy is not feasible, archivaltumor 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 andno deterioration within 2 weeks before the first dose.
Have a life expectancy of at least 12 weeks.
Exclusion
Exclusion Criteria:
Have received any of B7-H4-targeted therapies.
Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinesemedicines or other anti-tumor drugs within 28 days prior to the first dose of studydrug; or need to continue these drugs during the study.
Have received locoregional radiation therapy within 2 weeks prior to the first doseof study drug; more than 30% of bone marrow irradiation or wide-field radiationtherapy 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 4 weeks 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 restingECG.
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 poorlycontrolled hypertension, clinically significant bleeding symptoms or seriousarteriovenous thromboembolic events
Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a priorhistory of ILD or pneumonitis requiring high-dose systemic glucocorticoids.
Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitorAntibody-drug conjugate (ADCs)
PROC
Primary platinum refractory not permitted.
Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, orlow-grade endometrioid carcinoma not permitted.
- Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) notpermitted.
Study Design
Connect with a study center
GSK Investigational Site
Blacktown, New South Wales 2148
AustraliaActive - Recruiting
GSK Investigational Site
Macquarie University, New South Wales 2109
AustraliaActive - Recruiting
GSK Investigational Site
Sydney, New South Wales 2109
AustraliaSite Not Available
GSK Investigational Site
Leuven, 3000
BelgiumActive - Recruiting
GSK Investigational Site
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
GSK Investigational Site
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
GSK Investigational Site
Montreal, Quebec H2X 0A9
CanadaActive - Recruiting
GSK Investigational Site
Montréal, Quebec H2X 0A9
CanadaSite Not Available
GSK Investigational Site
Helsinki, 00290
FinlandActive - Recruiting
GSK Investigational Site
Lyon Cedex 08, 69373
FranceActive - Recruiting
GSK Investigational Site
Napoli, 80131
ItalySite Not Available
GSK Investigational Site
Roma, 00168
ItalySite Not Available
GSK Investigational Site
Rozzano MI, 20089
ItalyActive - Recruiting
GSK Investigational Site
Saitama, 350-1298
JapanActive - Recruiting
GSK Investigational Site
Shizuoka, 411-8777
JapanActive - Recruiting
GSK Investigational Site
Tokyo, 135-8550
JapanActive - Recruiting
GSK Investigational Site
Amsterdam, 1066 CX
NetherlandsActive - Recruiting
GSK Investigational Site
Barcelona, 08035
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28040
SpainActive - Recruiting
GSK Investigational Site
Pozuelo De AlarcOn Madr, 28223
SpainActive - Recruiting
GSK Investigational Site
Stockholm, 17164
SwedenActive - Recruiting
GSK Investigational Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
GSK Investigational Site
London, NW1 2PG
United KingdomActive - Recruiting
GSK Investigational Site
Lake Mary, Florida 32746
United StatesActive - Recruiting
GSK Investigational Site
Boston, Massachusetts 02114
United StatesActive - Recruiting
GSK Investigational Site
Detroit, Michigan 48201
United StatesActive - Recruiting
GSK Investigational Site
Dallas, Texas 75230
United StatesActive - Recruiting
GSK Investigational Site
West Valley City, Utah 84119
United StatesActive - Recruiting
GSK Investigational Site
Seattle, Washington 98109-1023
United StatesSite Not Available
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