Phase I Study of JSKN021 Drug to Assess Safety and Preliminary Effect in Adults with Advanced Malignant Solid Tumors

What this Trial Is About

Researchers are conducting a Phase I, open-label, multi-center clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of the drug JSKN021 in adults with advanced malignant solid tumors. This first-in-human study focuses on patients whose tumors have progressed after standard treatments, who are intolerant to standard therapies, or who have no access to such treatments. The trial aims to identify the optimal biological dose and recommended dose for future studies. Participants will receive JSKN021 administered intravenously at selected dose levels according to the study protocol. The trial includes multiple dose escalation cohorts followed by dose optimization cohorts to assess different dosing regimens. The study is randomized and evaluates various doses over time, with treatment continued under medical supervision. Each participant will undergo treatment cycles and monitoring as specified in the protocol. Throughout the study, participants will be closely monitored for adverse events, dose-limiting toxicities, and overall safety up to 30 days after the last dose or until new anti-tumor treatment begins. Researchers will assess tumor responses, disease control, progression-free survival, and overall survival over a period of up to 24 months. Pharmacokinetic parameters such as drug concentration levels and clearance will also be measured. Study visits will include clinical assessments, laboratory tests, imaging, and questionnaires to track treatment effects and participant well-being.

A Phase I Study of JSKN021 in Advanced Solid Tumors