Advanced solid tumors are cancers that have spread to other parts of the body. While many treatments exist, most people become resistant to them, and the cancer returns. Researchers are developing new treatments that combine different medicines for those who do not respond to single medicine. This study is looking at how safe and tolerable GSK5733584 is, how the body handles it, and how well it works when used with other cancer medicines. The study will include participants with advanced solid tumors who have either not responded to standard treatments or cannot tolerate them or have no available effective treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
392
GSK5733584 will be administered intravenously (IV).
Dostarlimab will be administered IV.
Bevacizumab will be administered IV.
Anticancer therapy 3 will be administered IV.
Anticancer therapy 4 will be administered IV.
GSK Investigational Site
Buenos Aires, Argentina
RECRUITINGGSK Investigational Site
CABA, Argentina
RECRUITINGGSK Investigational Site
Viedma, Argentina
RECRUITINGGSK Investigational Site
Liverpool, New South Wales, Australia
Part A: Percentage of participants with dose limiting toxicities (DLTs)
Time frame: Approximately 7 months
Part A: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by Severity
Time frame: Up to approximately 22 months
Part A: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by Frequency
Time frame: Up to approximately 22 months
Part B: Confirmed Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall confirmed (BOR) of Partial Response (PR) or better per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Up to approximately 37 months
Part A: Confirmed Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall confirmed (BOR) of PR or better per RECIST 1.1.
Time frame: Up to approximately 22 months
Parts A and B: Duration of response (DoR)
DoR is defined as the time from date of first documented evidence of PR or better to the date of disease progression or death due to any cause.
Time frame: Up to approximately 37 months
Parts A and B: Progression-free survival (PFS)
PFS is defined as time from the date of randomization (Part B) / first dose of study intervention (Part A or B if single arm) to the date of disease progression according to investigator assessment or death due to any cause, whichever occurs first.
Time frame: Up to approximately 37 months
Part B: Overall Survival (OS)
OS is defined as the time from randomization (or date of first dose if single arm) to the date of death due to any cause.
Time frame: Up to approximately 37 months
Parts A and B: Maximum observed concentration (Cmax) of GSK5733584
Time frame: Up to approximately 37 months
Parts A and B: Time to reach Cmax (tmax) of GSK5733584
Time frame: Up to approximately 37 months
Parts A and B: Trough concentration (Ctrough) of GSK5733584
Time frame: Up to approximately 37 months
Parts A and B: Area under the concentration-time curve (AUC) of GSK5733584
Time frame: Up to approximately 37 months
Parts A and B: Number of participants with Anti-drug antibodies (ADA)
Time frame: Up to approximately 37 months
Parts A and B: Number of participants with neutralizing antibody (nAb)
Time frame: Up to approximately 37 months
Parts A and B: Titers of ADA to GSK5733584
Time frame: Up to approximately 37 months
Parts A and B: Number of Participants with Clinically Significant Changes in Vital Signs, Laboratory parameters, and Electrocardiogram (ECG)
Time frame: Up to approximately 37 months
Part B: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by Frequency
Time frame: Up to approximately 37 months
Part B: Number of participants with adverse events (AEs), immune-mediated adverse events (imAEs), adverse events of special interest (AESI), serious adverse events (SAEs) by Severity
Time frame: Up to approximately 37 months
Parts A and B: Change from Baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
ECOG PS is used for measuring how the disease impacts a participants daily living abilities. The grades for the scale range from 0 (fully active) to 5 (dead), with increasing severity.
Time frame: Baseline and up to approximately 37 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Wollongong, New South Wales, Australia
RECRUITINGGSK Investigational Site
Brussels, Belgium
RECRUITINGGSK Investigational Site
Ghent, Belgium
RECRUITINGGSK Investigational Site
Leuven, Belgium
RECRUITINGGSK Investigational Site
Liège, Belgium
RECRUITINGGSK Investigational Site
Natal, Brazil
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