Actively Recruiting
Phase I Study of BL-M05D1 Intravenous Treatment for Adults with Locally Advanced or Metastatic Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-06-15
30
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating BL-M05D1 in patients with locally advanced or metastatic solid tumors in a phase I, open-label, multicenter study. This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of BL-M05D1 in individuals who have not responded to or cannot use standard treatments. Participation includes adults aged 18 to 75 years with measurable tumors and an expected survival of at least three months. Participants receive BL-M05D1 through intravenous infusion for an initial 3-week treatment cycle. Those who show clinical benefit may continue treatment in additional cycles. Treatment will stop if the disease progresses, intolerable side effects appear, or for other reasons. The study includes dose escalation to find the maximum tolerated dose and recommended dose for further trials. During the study, participants will undergo assessments for dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose up to about 24 months. Researchers will monitor adverse events, drug concentration levels, and immune responses, along with tumor response and disease control rates. Safety, tolerability, and pharmacokinetic data will be collected regularly to evaluate the treatment effects and patient health over time.
CONDITIONS
Brief Title
A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Research Team
S
Sa Xiao, PHD
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