drugset
drugset / Trial / NCT05115292

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

NCT05115292 ↗

Phase 1 Unknown 85 enrolled BJ Bioscience, Inc.
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2021-10-20
Primary completion
2024-10-20
Completion
2025-10-20

Drugs

EvaluationDrugModalityDoseRoute
Subject BJ-005 Monoclonal antibody — Intravenous

Indications

lymphoma