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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 85
- Locations
- 12
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Time Frame: 60 days after the last dose
Secondary Outcomes
No secondary outcomes reported