NCT05892718 A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
| NCT ID | NCT05892718 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | FBD Biologics Limited |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2027-05-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Able to understand and willing to sign the ICF. 2. Male and female subjects of ≥18 years of age. 3. Histologically/cytologically confirmed, locally advanced solid tumor: subjects with histologically or cytologically confirmed advanced solid tumors refractory to standard therapy, or for which no standard treatment exists or non-Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of therapy. 4. For subjects with advanced solid tumor - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline. 5. For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement). 6. Must have ECOG performance status of 0 to 2 at Screening. 7. Able to provide tumor tissue samples. 8. Have life expectancy of ≥12 weeks. Exclusion Criteria: 1. With known history of hypersensitivity to any components of HCB101