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

A First-in-Human, Multicenter, Open-label, 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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: BJ Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Solid Tumor or Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	BJ-005	dosed with intravenous infusion

Timeline

• Start date: 2021-10-20
• Primary completion: 2024-10-20
• Completion: 2025-10-20
• First posted: 2021-11-10
• Last updated: 2023-11-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study