Evaluating Safety and Effectiveness of RC288 Injection in Treating Advanced or Metastatic Solid Tumors Across Multiple Centers

What This Trial Is About

Researchers are studying RC288, a drug being evaluated for its safety, tolerability, and effectiveness in treating locally advanced unresectable or metastatic malignant solid tumors. The study aims to find the highest safe dose and the recommended dose for further testing while assessing how well the drug works at that dose. This is a Phase III clinical trial sponsored by RemeGen Co., Ltd., involving multiple centers. Participants receive RC288 through intravenous infusion. The study includes six predefined dose levels that increase stepwise in Phase I to determine the maximum tolerated or administered dose. In Phase II, the recommended dose is further tested across various cancer types to evaluate safety and effectiveness. Patients continue treatment until they experience unacceptable side effects, disease progression, or meet criteria for withdrawal. During the study, participants undergo regular assessments including imaging to measure tumor responses, evaluations for adverse events, and monitoring of vital organ functions. Researchers will collect data over 24 months on dose-limiting toxicities, side effect severity, and tumor response rates using established criteria. The trial lasts up to approximately four years with ongoing safety monitoring and efficacy assessments throughout.

A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors