Actively Recruiting
Phase I Study of LXP1788 Injection to Find Safe Dose and Assess Effects in Adults with Advanced Solid Tumors
Led by LaunXP Biomedical Co., Ltd. · Updated on 2025-03-19
24
Participants Needed
2
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating LXP1788 Injection in a Phase I open-label study for patients with advanced solid tumors that no longer respond to available treatments or have no effective options. The study aims to find the highest dose patients can tolerate and recommend a dose for future studies, while also assessing how the drug behaves in the body and its early effects on tumors. LXP1788 Injection is given intravenously through a port once a week for 60 minutes on days 1, 8, 15, and 22 of each 28-day treatment cycle. The study will determine the maximum tolerated dose and characterize the drugs plasma pharmacokinetics over two years. Patients will receive treatment in cycles, and the study will monitor safety, tolerability, dose-limiting toxicities, and any anti-tumor activity. Participants will undergo tumor biopsies or provide recent tissue samples for analysis. Regular assessments will include safety monitoring, laboratory tests, and evaluations of tumor response using established criteria. The research team will track adverse events and measure drug exposure levels. Overall participation may last up to two years while closely observing effects and safety.
CONDITIONS
Brief Title
A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.
Research Team
C
Chin- Hua Lin Clinical Research Director
P
Pin-Hung Kuo
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