GSK5764227
DrugParticipants will receive GSK5764227.
NCT Number: NCT07277270
The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
GSK Investigational Site, Tugun, Queensland, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive GSK5764227.
Participants will receive bevacizumab.
Participants will receive fluorouracil.
Participants will receive leucovorin.
Participants will receive enzalutamide.
Time frame: Up to approximately 31 weeks
Time frame: Up to approximately 31 weeks
Time frame: Up to approximately 31 weeks
Time frame: Up to approximately 31 weeks
Time frame: Up to approximately 112 weeks
Time frame: Up to approximately 112 weeks
Time frame: Up to approximately 112 weeks
Time frame: Up to approximately 112 weeks
Time frame: Up to approximately 112 weeks
ORR is defined as the proportion of participants who have achieved best observed response (BOR) of confirmed complete response (CR) or partial response (PR) as assessed by investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for Cohort A or per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) for Cohort B.
Time frame: Up to approximately 112 weeks
DCR18 is defined as the proportion of participants who have achieved CR or PR, or stable disease (SD) of ≥17 weeks as assessed by investigator according to PCWG3 for Cohort B.
Time frame: Up to approximately 112 weeks
DOR is defined as the time from the date of the first documented objective response (CR/PR) as assessed by investigator according to RECIST 1.1 for cohort A or PCWG3 for cohort B, until the date of the first documented disease progression (PD) or death due to any cause, whichever is earlier.
Time frame: Up to approximately 112 weeks
PFS is defined as the time from the date of first dose until the earliest date of documented disease progression as assessed by investigator according to RECIST 1.1 for cohort A.
Time frame: Up to approximately 112 weeks
rPFS is defined as the time from the date of first dose until the earliest date of documented PD per PCWG3-modified RECIST 1.1 (soft tissue lesion assessment) and/or PCWG3 bone lesion assessment for cohort B or death due to any cause.
Time frame: Up to approximately 112 weeks
PSA50 is defined as percentage of participants with a decrease of >=50% in the PSA concentration from the baseline PSA value, confirmed at least 3 weeks later (cohort B)
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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