Phase I Study of SYS6040 Injection to Assess Safety and Effectiveness in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating SYS6040 for injection in adults with advanced solid tumors, including small cell lung cancer and other advanced solid tumors. This first-in-human Phase I study aims to assess the safety, tolerability, how the drug is processed in the body pharmacokinetics, and initial signs of effectiveness when used alone. The study follows a dose escalation phase with backfill and a cohort expansion phase to gather comprehensive data on SYS6040. Participants will receive SYS6040 through intravenous infusion in five predefined dose groups during the dose escalation phase. Treatment cycles last 21 days, with decisions on dose changes based on observed toxicity in the first cycle. Following dose escalation, participants in the cohort expansion phase will receive the recommended Phase 2 dose every 3 weeks until disease progression, intolerable side effects, withdrawal, or other reasons for stopping. The study treatment continues as long as medically appropriate. During the study, participants will undergo regular assessments of safety, side effects, and how the drug behaves in the body. Researchers will monitor adverse events, laboratory tests, and tumor response using standard criteria. The primary outcomes include dose-limiting toxicities and overall response rate, tracked for up to approximately two years. Participants may be followed closely with ongoing evaluations throughout treatment to understand the drugs effects and tolerability.

A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors