Phase III Study of FH-006 Injection in Adults With Advanced Malignant Solid Tumors to Evaluate Safety, Dosage, and Effectiveness

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of FH-006 in adults with advanced malignant solid tumors. The study aims to find the highest dose patients can tolerate, determine the recommended dose for future trials, and gather early data on how well the treatment works. Participants receive FH-006 through intravenous injection either once every two weeks over a 28-day treatment period, or once every three weeks over a 21-day treatment period. The study includes dose escalation phases to identify maximum tolerated or administered doses and a dose expansion phase to further evaluate the recommended dose. Throughout the study, participants undergo monitoring for dose-limiting toxicities and adverse events for up to 30 days after their last dose. Researchers assess serious side effects, immune reactions to the drug, and treatment efficacy over an average of two years. The total duration and detailed assessments ensure thorough evaluation of FH-006s impact and safety.

Phase I/II Clinical Study of FH-006 for Injection in Patients With Malignant Solid Tumors