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

Study Overview
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Brief Summary
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This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).

Official Title
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A First-in-Human, Multicenter, Open-label, 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

Conditions
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Advanced Solid Tumor or Lymphoma

Intervention / Treatment
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* Biological: BJ-005


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1<br>BJ-005 dose escalation | Biological: BJ-005<br>* dosed with intravenous infusion<br>|
| Experimental: Arm 2<br>BJ-005 cohort expansion | Biological: BJ-005<br>* dosed with intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study. |  | 60 days after the last dose | 
| To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-005 following IV infusion in patients with advanced solid tumor or lymphoma. |  | 60 days after the last dose |