Phase 1 Study to Assess Safety and Early Effectiveness of JMT108 Injection for Adults With Advanced Malignant Tumors

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to assess JMT108 injection in adults with advanced malignant tumors. The study aims to evaluate the safety, tolerability, how the drug moves through the body, and early signs of anti-tumor activity. It focuses on patients whose tumors no longer respond to standard treatments or who have no available standard options. The trial is sponsored by Shanghai JMT-Bio Inc. and includes participants aged 18 and older. Participants will receive JMT108 or other study drugs such as Pembrolizumab or Ivonescimab through intravenous infusions every three weeks in 3-week cycles. The study includes dose-escalation and dose-expansion phases to find the recommended dose and schedule for future studies. The treatment is open-label, meaning both researchers and participants know what is being administered. During the study, participants will undergo tumor evaluations using established criteria, along with regular blood tests and physical exams to monitor organ function and side effects. Researchers will track dose-limiting toxicities for about 28 days and adverse events throughout the study, which typically lasts about one year. The trial also measures drug levels in the blood. Participants are expected to have a performance status allowing daily activities and a predicted survival of at least three months.

First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors