Phase 1 Study to Evaluate Safety, Tolerability, and Effects of GSK5764227 Alone and With Other Medicines in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating Risvutatug rezetecan Ris-Rez, also known as GSK5764227, in people with advanced solid tumors. This Phase 1 clinical study aims to assess the safety, tolerability, clinical activity, and how Ris-Rez is processed in the body. The study also examines how Ris-Rez levels change over time when given alone or combined with other cancer medicines such as carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab, tarlatamab, and dostarlimab. The study includes several treatment groups involving dose escalation, optimization, and expansion phases using Ris-Rez either alone or with other therapies. Participants will receive Ris-Rez and may also be given one or more of the other listed medicines, depending on their assigned group. Treatments will be carefully administered and monitored throughout the study period. Participants will be involved for up to approximately 33 months, during which researchers will monitor side effects, vital signs, lab tests, tumor response, and performance status. Assessments include tracking adverse events, dose changes, and clinical responses to treatment. Blood samples will be collected to measure drug levels and antibodies against the treatment. Safety and effectiveness measures such as progression-free survival and disease control rates will be evaluated over time.

A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)