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
Phase 1
Active, not recruiting
- Conditions
- Advanced Solid Tumor or Lymphoma
- Interventions
- Biological: BJ-005
- Registration Number
- NCT05115292
- Lead Sponsor
- BJ Bioscience, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 85
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm 2 BJ-005 BJ-005 cohort expansion Arm1 BJ-005 BJ-005 dose escalation
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Mayo Clinic - Florida
🇺🇸Jacksonville, Florida, United States
Carolina BioOncology
🇺🇸Huntersville, North Carolina, United States
Next Oncology
🇺🇸Austin, Texas, United States
Hematology/Oncology Assoc. of the Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic - Phoenix
🇺🇸Phoenix, Arizona, United States