Actively Recruiting
Phase 1 Study of HDM2017 to Assess Safety and Early Effects in Adults With Advanced Malignant Solid Tumors
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-12-10
96
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating HDM2017 in patients with advanced malignant solid tumors in this phase I clinical study. The study aims to assess the safety, tolerability, how the drug moves through the body pharmacokinetics, and early signs of antitumor activity in adults with advanced solid tumors who have limited or no effective treatment options. Participants will receive increasing doses of HDM2017 through intravenous infusion. After determining the maximum tolerated dose, at least two dose levels will be expanded to find the recommended dose for future studies. This dose escalation and expansion approach helps understand how best to use HDM2017 for these tumors. During the study, participants will undergo regular visits with treatment, lab tests, and other trial procedures. Researchers will monitor adverse events, drug levels in the blood, immune responses, tumor responses, and survival outcomes up to 30 days after the last dose. The study is designed to last until July 2027 for adults aged 18 to 75 with good performance status and measurable tumors.
CONDITIONS
Brief Title
A Phase 1 Study of HDM2017 in Advanced Solid Tumors
Research Team
R
Ruichao Zeng
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