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Phase 1 Study of HDM2005 to Test Safety and Early Effects in Adults With Relapsed or Refractory B-cell Lymphoma and Advanced Solid Tumors
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2024-09-26
111
Participants Needed
8
Research Sites
83 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of an experimental drug called HDM2005 in patients with relapsed or refractory B-cell lymphoma and advanced solid tumors. This is a first-in-human phase 1 study aiming to find a suitable dose and observe initial responses in these patients who have limited treatment options. The study has two parts a dose escalation phase where participants receive increasing doses of HDM2005 through an intravenous infusion on Day 1 of repeated 21-day cycles, and a dose expansion phase where participants are given the recommended dose for further evaluation. This approach helps determine the best dose and monitors how patients respond over time. Participants will have scans such as CT or MRI to measure tumor lesions, blood tests to check drug levels and immune response, and safety assessments to monitor side effects. The study measures include dose-limiting toxicities, adverse events, and the tumor response rate. The trial may last up to approximately 3.5 years, during which participants will be closely monitored for treatment effects and safety.
CONDITIONS
Brief Title
A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
Research Team
J
Jun Zhou, Master
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