First-in-Human Study of JR8603 Given by IV Infusion in Patients With Advanced Solid Tumors Who Have Tried Other Treatments

What this Trial Is About

Researchers are studying JR8603, an investigational drug, to see if it is safe and effective for patients with advanced solid tumors that have not improved after standard treatments. This early phase, first-in-human, open-label trial focuses on patients with locally advanced or metastatic solid tumors who have progressed despite or cannot tolerate standard therapies. The study aims to find the right dose and observe preliminary effects of JR8603. The study has two parts Dose Escalation and Dose Expansion. JR8603 is given as a short intravenous infusion on Days 1, 8, and 15 of repeated 28-day cycles. During Dose Escalation, doses start low and may increase to find the maximum tolerated dose using a stepwise approach with small groups of patients. Dose Expansion then evaluates the drug further at selected doses in specific groups of patients with gastric, esophagogastric junction, or colorectal cancers. Participants will have scans CT or MRI to measure tumor response every 8 weeks for the first year, then every 12 weeks afterward. Researchers will collect blood samples to study how the drug is processed in the body. Safety is closely monitored using standard criteria, and various outcomes such as adverse events, response rates, and survival will be tracked up to about one year after the last dose. Total participation time varies based on individual treatment and response.

A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors