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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
dosed with intravenous infusion
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
Hematology/Oncology Assoc. of the Treasure Coast
Port Saint Lucie, Florida, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
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
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Carolina BioOncology
Huntersville, North Carolina, United States
Next Oncology
Austin, Texas, United States