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

Status unconfirmed · Phase 1

Conditions studied: Advanced Solid Tumor or Lymphoma

In brief

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).

Key facts

Study ID

NCT05115292

Run by

BJ Bioscience, Inc.

People needed

85

Starts

2021-10-20

Expected to finish

2025-10-20

Last updated by the study team

2023-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 years.
• 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.
• Histologically or cytologically confirmed advanced solid tumors or lymphoma
• Measurable or evaluable disease per RECIST v1.1
• ECOG performance status 0 or 1
• Life expectancy ≥3 months
• Adequate hepatic function
• Calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation)
• Adequate Hematological function
• Prothrombin time, international normalized ratio or activated partial thromboplastin time < 1.5 × ULN
• Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy

You may not qualify if…

• Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment.
• Symptomatic primary central nervous system (CNS) tumor of CNS metastases.
• Uncontrolled hypertension.
• Significant thrombotic or hemorrhagic events.
• Prior CAR-T therapy
• Severe cardiovascular disease.
• Active infection requiring therapy
• Active HIV, hepatitis B or hepatitis C virus
• Active tuberculosis
• Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry
• Pregnant or breast-feeding females
• Active or history of autoimmune disease or inflammatory disorders

Where it is running

• 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
• Carolina BioOncology — Huntersville, North Carolina, United States
• Next Oncology — Austin, Texas, United States

Full record on ClinicalTrials.gov

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