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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

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ClinicalTrials.gov Identifier: NCT05115292
Recruitment Status : Recruiting
First Posted : November 10, 2021
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
BJ Bioscience, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor or Lymphoma Biological: BJ-005 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : October 20, 2023
Estimated Study Completion Date : October 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




Primary Outcome Measures :
  1. 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. [ Time Frame: 60 days after the last dose ]
  2. 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. [ Time Frame: 60 days after the last dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05115292


Contacts
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Contact: Joe Zhang, MD 203-437-6518 joe.zhang@bjbioscience.com

Locations
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United States, Arizona
Mayo Clinic - Phoenix Recruiting
Phoenix, Arizona, United States, 85054
Contact: Mitesh Borad, MD    480-342-4800    borad.mitesh@mayo.edu   
Contact: Katherine Gano       Gano.Katherine@mayo.edu   
United States, Florida
Mayo Clinic - Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Hani Babiker, MD    904-953-2000    Babiker.Hani@mayo.edu   
Contact: Katherine Gano       Gano.Katherine@mayo.edu   
Hematology/Oncology Assoc. of the Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
Contact: Nicholas Iannotti, MD    772-408-5159    niannotti@hemoncfl.com   
Contact: Christine Gerdes       cgerdes@hemoncfl.com   
United States, Minnesota
Mayo Clinic - Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Thanh Ho, MD    507-284-2511    Ho.Thanh@mayo.edu   
Contact: Katherine Gano       Gano.Katherine@mayo.edu   
United States, North Carolina
Carolina BioOncology Recruiting
Huntersville, North Carolina, United States, 28078
Contact: John Powderly, MD    704-947-6599    jpowderly@carolinabiooncology.org   
Contact: Ashley Wallace       awallace@carolinabiooncology.org   
United States, Texas
Next Oncology Recruiting
Austin, Texas, United States, 78758
Contact: Andrae Vandross,, M.D.    210-580-9500    mailto:avandross@nextoncology.com   
Sponsors and Collaborators
BJ Bioscience, Inc.
Investigators
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Study Director: Vicky Gao, MD BJ Bioscience, Inc.
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Responsible Party: BJ Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT05115292    
Other Study ID Numbers: BJ-005-01-001US
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases