A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 as Monotherapy and in Combination in Participants With Advanced Solid Tumors
GlaxoSmithKline
Summary
The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227. The study will also see how the levels of Ris-Rez will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab, tarlatamab, dostarlimab
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria * Male or female participants at least 18 years of age (≥18 years) * Participants with histologically confirmed advanced/metastatic solid tumors, as defined per study phase and cohort, as follows: Phase 1a: 1. Participants with advanced/metastatic solid tumors. 2. For monotherapy dose escalation: participants must have progressed on or become intolerant to all available SOC therapies. 3. For combination dose escalation: participants must have received 3 or fewer prior lines of systemic anticancer therapy in the advanced/metastatic setting * Has at least 1 target lesio…