Actively Recruiting
Phase 1 Study of SSGJ-709 to Assess Safety and Anti-Tumor Effects in Adults with Advanced Malignant Tumors
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2026-01-28
15
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new drug called SSGJ-709 in patients with advanced malignant tumors. This open-label phase 1 study aims to assess the safety, how the drug moves through the body, and its anti-tumor activity. The trial focuses on patients with various advanced cancers, including some specific tumor types, who have limited treatment options. The study includes two phases a dose escalation phase where the amount of SSGJ-709 is gradually increased to find the highest safe dose, and a dose expansion phase where the drug is given at a specific dose to more participants to further evaluate safety and effectiveness. Participants receive an infusion of SSGJ-709 once every 3 weeks. The dose escalation uses an accelerated titration and traditional 33 design with five dose levels. Participants will visit the clinic every 3 weeks for checkups and tests. Researchers will monitor safety by tracking dose-limiting toxicities and treatment-related adverse events over about one year. They will also measure how the drug is processed in the body and evaluate tumor response every 6 weeks. The total study duration includes ongoing safety and effectiveness assessments throughout the trial period.
CONDITIONS
Brief Title
A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors
Research Team
A
Andrew Parsonson
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