A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid o… (NCT05892718) | Clinical Trial Compass
RecruitingPhase 1
A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
United States, China80 participantsStarted 2023-10-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to understand and willing to sign the ICF.
✓. Male and female subjects of ≥18 years of age.
✓. 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.
✓. 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.
✓. For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement).
✓. Must have ECOG performance status of 0 to 2 at Screening.
✓. Able to provide tumor tissue samples.
✓. Have life expectancy of ≥12 weeks.
Exclusion criteria
✕. With known history of hypersensitivity to any components of HCB101.
✕. Known active or untreated CNS metastases and/or carcinomatous meningitis.
✕. Have undergone a major surgery or radical radiotherapy or palliative radiotherapy or have used a radioactive drug that is not completed at least 2 weeks prior to the first dose of HCB101.
What they're measuring
1
Number/incidence and percentage of subjects with adverse events, including ADA.
✕. Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia.
✕. With known inherited or acquired bleeding disorder or bleeding diathesis. .
✕. Have RBC transfusion within 4 weeks prior to Screening.
✕. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.