A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC278 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called RC278 for treating locally advanced unresectable or metastatic malignant solid tumors. The study aims to find the highest safe dose, the recommended dose for further testing, and to assess how well RC278 works at that dose. This trial is a combined Phase I/II clinical study sponsored by RemeGen Co., Ltd., focusing on patients with solid tumors who meet specific health criteria. The study includes several stages starting with five groups receiving increasing doses of RC278 to identify the maximum tolerated dose or maximum administered dose. Following this dose-escalation, selected doses will be further tested in a randomized manner to determine the recommended Phase II dose. In the expansion phase, this dose will be studied in different types of cancers to further evaluate safety and effectiveness. RC278 is given intravenously every three weeks, and treatment continues until unacceptable side effects occur, the disease progresses, or the participant withdraws. Participants will be monitored for up to 24 months to track dose-limiting toxicities, adverse events, and tumor response using standard criteria. Assessments include imaging to measure tumor size, safety evaluations, and pharmacokinetic testing. The study collects data on how well participants tolerate the drug and how their tumors respond. Follow-up continues throughout the study to ensure participant safety and to gather comprehensive information on the drug's effects.

A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors