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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | BJ-005 dose escalation |
|
| Arm 2 | Experimental | BJ-005 cohort expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BJ-005 | Biological | dosed with intravenous infusion |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicky Gao, MD | BJ Bioscience, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Phoenix | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic - Florida |
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| Jacksonville |
| Florida |
| 32224 |
| United States |
| Hematology/Oncology Assoc. of the Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Carolina BioOncology | Huntersville | North Carolina | 28078 | United States |
| Next Oncology | Austin | Texas | 78758 | United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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