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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumor or Lymphoma
• Intervention / Treatment: Biological: BJ-005

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic - Phoenix
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Florida
    • Port Saint Lucie, Florida, United States, 34952
      • Hematology/Oncology Assoc. of the Treasure Coast
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology
  • Texas
    • Austin, Texas, United States, 78758
      • Next Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm1; BJ-005 dose escalation	Biological: BJ-005; dosed with intravenous infusion
Experimental: Arm 2; BJ-005 cohort expansion	Biological: BJ-005; dosed with intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: BJ Bioscience, Inc.
• Investigators: Study Director: Vicky Gao, MD, BJ Bioscience, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): October 20, 2025

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: BJ-005-01-001US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No