A Phase 1/2 First-Time-In-Human, Open-Label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-Cancer Agents in Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
GlaxoSmithKline
Summary
The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Male participants ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 195 days, after the last dose of study intervention: Refrain from donating sperm PLUS eithe…
Interventions
- DrugGSK5458514
GSK5458514 will be administered.
Locations (15)
- GSK Investigational SiteDenver, Colorado
- GSK Investigational SiteNashville, Tennessee
- GSK Investigational SiteMontreal, Quebec
- GSK Investigational SiteMontreal, Quebec
- GSK Investigational SiteLyon
- GSK Investigational SiteVillejuif