Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of BJ-001, and IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors (FIH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04294576
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : June 26, 2020
Sponsor:
Collaborators:
Iqvia Pty Ltd
PPD
Information provided by (Responsible Party):
BJ Bioscience, Inc.

Brief Summary:
The purpose of this study is to assess the safety and tolerability of BJ-001, a human IL-15 fusion protein, administered via subcutaneous injections, as a single agent and in combination with PD-1 or PD-L1 Inhibitor in adult patients with Locally Advanced/Metastatic Solid Tumors

Condition or disease Intervention/treatment Phase
Locally Advanced/Metastatic Solid Tumors Drug: BJ-001 Drug: PD-1 or PD-L1 inhibitor Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description: no masking is used. All involved know the identity of the intervention assignment.
Primary Purpose: Treatment
Official Title: First-in-human (FIH), Open-Label, Phase 1a (Dose Escalation)/Phase 1b (Expansion Cohort) Trial of BJ-001 as a Single Agent and in Combination With PD-1 or PD-L1 Inhibitor in Patients With Locally Advanced/Metastatic Solid Tumors
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : April 29, 2022
Estimated Study Completion Date : October 22, 2022

Arm Intervention/treatment
Experimental: Arm 1; BJ-001
Phase 1a Part 1 and Part 2: dose escalation for BJ-001 as single agent
Drug: BJ-001
BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.

Experimental: Arm 2; BJ-001 and PD-1 or PD-L1 inhibitor
Phase 1a Part 3: dose escalation for BJ-001 in combination with an PD-1 or PD-L1 inhibitor. Approximately Phase 1b: expansion cohorts for the combination of BJ-001 and an PD-1 or PD-L1 inhibitor.
Drug: BJ-001
BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.

Drug: PD-1 or PD-L1 inhibitor

BJ-001 dosed via SC injection in combination with PD-1 or PD-L1 inhibitor.

One cycle is 6 weeks.





Primary Outcome Measures :
  1. Frequency of adverse events (AEs) and SAE [ Time Frame: 90 days after the last dose ]
    To assess the safety and tolerability of BJ-001 as a single agent administered s.c. at escalating dose levels in adults with solid tumors.

  2. Severity of AEs in patients with solid tumors enrolled in the study. [ Time Frame: From Day 1 of treatment up to 30 days after last dose ]
    To assess the safety and tolerability of s.c. BJ-001 administered at escalating dose levels in combination with PD-1 or PD-L1 inhibitor. in adults with solid tumors.

  3. Dose limiting toxicities (DLTs) BJ-001 as a single agent [ Time Frame: at the end of week 4 after first dose ]
    To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-001 as a single agent.

  4. Dose limiting toxicities (DLTs) BJ-001 in combination with PD-1 or PD-L1 inhibitor. [ Time Frame: at the end of week 4 after first dose ]
    To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of s.c. BJ-001 administered at escalating dose levels in combination with pembrolizumab in adults with solid tumors.


Secondary Outcome Measures :
  1. Immunogenicity of BJ-001 as a single agent and in combination with PD-1 or PD-L1 inhibitor. [ Time Frame: 90 days after last dose ]
    The frequency of anti-drug antibodies (ADA) against BJ-001 as a single agent and in combination with PD-1 or PD-L1 inhibitor.

  2. Pharmacokinetic (PK) AUC0-τ samples patients treated with BJ-001 as a single agent and in combination with PD-1 or PD-L1 inhibitor. [ Time Frame: 24 weeks ]
    PK parameters (AUC0-τ) following the first dose and the fourth dose

  3. Pharmacokinetic (PK) Cmax samples patients treated with BJ-001 as a single agent and in combination with PD-1 or PD-L1 inhibitor. [ Time Frame: 24 weeks ]
    PK parameters (Cmax) following the first dose and the fourth dose

  4. Pharmacokinetic (PK) Ctrough samples patients treated with BJ-001 as a single agent and in combination with PD-1 or PD-L1 inhibitor. [ Time Frame: 24 weeks ]
    PK parameters (Ctrough) following the first dose and the fourth dose

  5. Pharmacokinetic (PK) Tmax samples patients treated with BJ-001 as a single agent and in combination with PD-1 or PD-L1 inhibitor. [ Time Frame: 24 weeks ]
    PK parameters (Tmax) following the first dose and the fourth 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.


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

Inclusion Criteria:

  • Phase 1a patients must have locally advanced or metastatic solid tumors,
  • Phase 1b patients must have locally advanced or metastatic and/or non-resectable head and neck squamous cell carcinoma, cholangiocarcinoma, stomach cancer, melanoma, pancreatic cancer, NSCLC (as high expression of αVβ3, αVβ5, or αVβ6 have been reported for these tumors)

    • Measurable disease: For Phase 1a patients can have non-measurable or measurable disease. For all other parts: measurable disease defined by RECIST v1.1 is required
    • For Phase 1a Part 3 and Phase 1b patients (combination treatment) must be refractory or relapsed to anti-PD-1, anti-PD-L1 or anti-CTLA4 checkpoint inhibitors for all tumor types, For Part 1 and Part 2 of Phase 1a (BJ-001 single agent treatment) both checkpoint inhibitor naïve or refractory/relapsed patients will be considered.
  • Patient who have diagnosis for which treatment with PD-1/PD-L1 inhibitors to be enrolled. Patients previously treated with PD-1/PD-L1 inhibitors and who have progressed are eligible. to be enrolled.

    • Adequate hematologic function,
    • Adequate hepatic function, defined by all of the following:
    • Adequate renal function defined by estimated creatinine clearance ≥ 45 mL/min (Cockcroft and Gault formula
    • ECOG Performance Status (PS) of 0-2.
    • No history of any hematopoietic malignancy.
    • No active or history of clinically significant autoimmune disease (as defined by previously requiring immunosuppressive therapy).

Exclusion Criteria:

  • Pregnant or nursing females.
  • Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug. Exceptions: Hormone replacement therapy, testosterone, or oral contraceptives (LHRH antagonists are allowed).
  • Patients previously treated with an anti PD-1/PD-L1 targeting agent who have had any prior history of immune-mediated pneumonitis, any immune-mediated toxicity of ≥ Grade 3,
  • Patients with a history of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity.
  • Patients with a history of pneumonitis, myocarditis, history of Stevens-Johnson syndrome or toxic epidermal necrolysis.
  • Patients who have undergone a bone marrow transplantation, solid organ transplantation, or stem cell transplant.
  • Patients with unresolved AEs > Grade 1 from prior anticancer therapy.
  • Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to enrollment.
  • Uncontrolled primary central nervous system (CNS) tumors or CNS metastases; based on screening.
  • Patients with active autoimmune disease or a documented medical history of autoimmune disease managed by replacement therapy.

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): NCT04294576


Contacts
Layout table for location contacts
Contact: Grace Yu, MD 347-620-8969 grace.yu@bjbioscience.com
Contact: Joe Zhang 203-437-6518 joe.zhang@bjbioscience.com

Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Haeseong Park, MD    314-362-7355    haeseongpark@wustl.edu   
United States, New York
Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Deborah Doroshow, MD    212-241-6974    deborah.doroshow@mssm.edu   
United States, South Carolina
Greenville Hospital System University Medical Center (ITOR) Recruiting
Greenville, South Carolina, United States, 29605
Contact: Ki Chung, MD    864-455-3600    ki.chung@prismahealth.org   
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Raghad Abdul Karim, MD    210-580-9517    rkarim@nextoncology.com   
United States, Washington
Northwest Medical Specialities Recruiting
Tacoma, Washington, United States, 98405
Contact: Jorge Chaves, MD    253-428-8700    chaves_research@nwmsonline.com   
Sponsors and Collaborators
BJ Bioscience, Inc.
Iqvia Pty Ltd
PPD
Investigators
Layout table for investigator information
Study Director: Grace Yu, MD BJ Bioscience
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: BJ Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT04294576    
Other Study ID Numbers: BJ-001-01-001US
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BJ Bioscience, Inc.:
FIH
Solid Tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms