An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Select… (NCT06487624) | Clinical Trial Compass
RecruitingPhase 1
An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors
United States, China50 participantsStarted 2025-04-02
Plain-language summary
The purpose of this study is to find out whether IV injection of HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas 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 be willing to sign the ICF.
✓. Male and female subjects of ≥18 years of age.
✓. For subjects with advanced solid tumors - must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
✓. For subjects with classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
✓. Must have ECOG performance status of 0 to 1 at Screening.
✓. Able to provide tumor tissue samples.
✓. Have a life expectancy of ≥12 weeks.
Exclusion criteria
✕. With known history of hypersensitivity to any components of HCB301.
✕. Known active or untreated CNS metastases and/or carcinomatous meningitis.
✕. Have undergone a major surgery or radical radiotherapy within 28 days or palliative radiotherapy within 14 days or have used a radioactive drug within 56 days prior to the first dose of HCB301.
. 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.