Phase I Study of SSGJ-612 Given by IV to Adults with Advanced HER2-Positive Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, how the body processes the drug, and the anti-tumor effects of SSGJ-612 in adults aged 18 to 75 with advanced malignant solid tumors that express HER2. This open-label Phase I study focuses on patients whose tumors have not responded to standard treatments or who cannot undergo surgery or certain therapies. The trial has two parts a dose escalation phase and a dose expansion phase. During dose escalation, participants receive one of five increasing doses of SSGJ-612 via intravenous injection to find the maximum safe dose. If doses are well tolerated, those doses will be further tested in larger groups during the dose expansion phase. Participants will be closely monitored for side effects and how their tumors respond over about one year. Researchers will assess tumor size using RECIST criteria and measure drug levels in the blood. Safety checks include tracking adverse events and dose-limiting toxicities. The study includes regular evaluations to understand the drugs effects and tolerability throughout the treatment period.

A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors