An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors

ConditionsAdvanced Solid Tumor Refractory Hodgkin Lymphoma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorFBD Biologics Limited

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Clinically significant cardiovascular condition.