Actively Recruiting
Phase 1 Study Evaluating Safety and Effectiveness of HCB101 IV Injection for Advanced Solid Tumors and RelapsedRefractory Non-Hodgkin Lymphoma
Led by FBD Biologics Limited · Updated on 2026-02-04
80
Participants Needed
8
Research Sites
128 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of HCB101, an intravenous Fc-fusion protein targeting the SIRP-CD47 pathway, in adults aged 18 years and older with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. This Phase 1, open-label, multi-center study aims to identify the maximum tolerated dose and monitor any side effects in participants who have failed standard therapies or are considered unsuitable for such treatments. Participants will receive HCB101 through intravenous injection at gradually increasing doses, starting from 0.08 mgkg up to 36 mgkg sequentially. Treatment will continue until unacceptable adverse events, disease progression, withdrawal, loss to follow-up, death, or study termination. The study involves dose escalation to determine the optimal dose level for further research. During the study, participants will undergo regular safety monitoring, blood sampling for pharmacokinetics, and tumor assessments using established criteria. Researchers will measure adverse event rates, immune responses, tumor response rates, and drug concentration over a 12-month period. The study includes comprehensive evaluation of anti-tumor effects and safety, with participants followed until study completion or withdrawal.
CONDITIONS
Brief Title
A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
Research Team
F
FBD Clinical
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