Advanced Solid Tumor or Lymphoma
Conditions
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).
Interventions
BIOLOGICALBJ-005
dosed with intravenous infusion
Sponsors
BJ Bioscience, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥ 18 years. 2. 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. 3. Histologically or cytologically confirmed advanced solid tumors or lymphoma 4. Measurable or evaluable disease per RECIST v1.1 5. ECOG performance status 0 or 1 6. Life expectancy ≥3 months 7. Adequate hepatic function 8. Calculated creatinine clearance (CrCL) \> 50 mL/min (Cockroft-Gault Equation) 9. Adequate Hematological function 10. Prothrombin time, international normalized ratio or activated partial thromboplastin time \< 1.5 × ULN 11. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy
Exclusion criteria
1. Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment. 2. Symptomatic primary central nervous system (CNS) tumor of CNS metastases. 3. Uncontrolled hypertension. 4. Significant thrombotic or hemorrhagic events. 5. Prior CAR-T therapy 6. Severe cardiovascular disease. 7. Active infection requiring therapy 8. Active HIV, hepatitis B or hepatitis C virus 9. Active tuberculosis 10. Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry 11. Pregnant or breast-feeding females 12. Active or history of autoimmune disease or inflammatory disorders
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed