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A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Enrollment target: 60 to 80v7
  2. Primary completion date: May 30, 2025 to May 30, 2027
    • Study sites: 7 to 8
    • Study completion date: Nov 15, 2025 to Nov 15, 2029
    v6
  3. Study sites: 6 to 7v5
  4. Eligibility criteria expanded, about 37 words
    • Site details revised at 6 of 6 sites
    v4
  5. Trial status: Enrolling by Invitation to Recruiting
    • Start date changed from estimate of Aug 18, 2023 to Oct 2, 2023
    • Site details revised at 6 of 6 sites
    v3
  6. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 6
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to find out whether IV injection of HCB101 is an effective treatment for different types of advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.
Trial Details
NCT Number NCT05892718
Lead Sponsor FBD Biologics Limited
Conditions
(from sponsor)		 Advanced Solid Tumor, Refractory Non-Hodgkin Lymphoma
Related terms Lymphoma, Lymphoma, Non-Hodgkin
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov