A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma

Inclusion Criteria

• Male or female ≥ 18 years.
• Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
• Histologically or cytologically confirmed advanced solid tumors or lymphoma
• Measurable or evaluable disease per RECIST v1.1
• ECOG performance status 0 or 1
• Life expectancy ≥3 months
• Adequate hepatic function
• Calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation)
• Adequate Hematological function
• Prothrombin time, international normalized ratio or activated partial thromboplastin time < 1.5 × ULN
• Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy

Exclusion Criteria

• Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment.
• Symptomatic primary central nervous system (CNS) tumor of CNS metastases.
• Uncontrolled hypertension.
• Significant thrombotic or hemorrhagic events.
• Prior CAR-T therapy
• Severe cardiovascular disease.
• Active infection requiring therapy
• Active HIV, hepatitis B or hepatitis C virus
• Active tuberculosis
• Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry
• Pregnant or breast-feeding females
• Active or history of autoimmune disease or inflammatory disorders