Phase I Study of SKB500 Injection to Evaluate Safety, Tolerability, and Antitumor Effects in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are studying SKB500 in people with advanced solid tumors to understand its safety, how the body processes it, immune response, and effects against tumors. This Phase I clinical trial includes multiple stages dose-escalation, dose-expansion, and indication-expansion phases to evaluate these aspects in detail. Participants will receive SKB500 through an intravenous infusion once every three weeks. The study will monitor how well participants tolerate the treatment, any side effects, and how the drug behaves in the body across the different study phases. During the study, participants will undergo regular assessments to track adverse events, dose-limiting toxicities, and antitumor activity up to three years. Evaluations include measuring drug levels over time, immune responses, and overall safety. Participants will be followed closely throughout the treatment and observation periods to gather comprehensive data.

A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors