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

November 7, 2023 updated by: BJ Bioscience, Inc.

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 Pembrolizumab in Patients With Locally Advanced/Metastatic Solid Tumors

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 pembrolizumab in adult patients with Locally Advanced/Metastatic Solid Tumors

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System University Medical Center (ITOR)
    • Texas
      • San Antonio, Texas, United States, 78229
        • NEXT Oncology
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 pembrolizumab to be enrolled. Patients previously treated with pembrolizumab 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1; BJ-001
Phase 1a Part 1, Part 2, and Part 4: 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 pembrolizumab

Phase 1a Part 3 and Part 5: dose escalation for BJ-001 in combination with Pembrolizumab

Phase 1b: expansion cohorts for the combination of BJ-001 and pembrolizumab
Drug: BJ-001
BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.
Drug: Pembrolizumab

BJ-001 dosed via SC injection in combination with Pembrolizumab

One cycle is 6 weeks.

Other Names:
  • Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days after the last dose
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 Pembrolizumab inhibitor. in adults with solid tumors.
From Day 1 of treatment up to 30 days after last dose
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.
at the end of week 4 after first dose
Dose limiting toxicities (DLTs) BJ-001 in combination with pembrolizumab 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.
at the end of week 4 after first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of BJ-001 as a single agent and in combination with Pembrolizumab.
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 Pembrolizumab.
90 days after last dose
Pharmacokinetic (PK) AUC0-τ samples patients treated with BJ-001 as a single agent and in combination with Pembrolizumab.
Time Frame: 24 weeks
PK parameters (AUC0-τ) following the first dose and the fourth dose
24 weeks
Pharmacokinetic (PK) Cmax samples patients treated with BJ-001 as a single agent and in combination with Pembrolizumab.
Time Frame: 24 weeks
PK parameters (Cmax) following the first dose and the fourth dose
24 weeks
Pharmacokinetic (PK) Ctrough samples patients treated with BJ-001 as a single agent and in combination with Pembrolizumab.
Time Frame: 24 weeks
PK parameters (Ctrough) following the first dose and the fourth dose
24 weeks
Pharmacokinetic (PK) Tmax samples patients treated with BJ-001 as a single agent and in combination with Pembrolizumab.
Time Frame: 24 weeks
PK parameters (Tmax) following the first dose and the fourth dose
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BJ Bioscience, Inc.

Collaborators

Merck Sharp & Dohme LLC
PPD

Investigators

  • Study Director: Joe Zhang, PhD, BJ Bioscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2019

Primary Completion (Estimated)

April 29, 2024

Study Completion (Estimated)

October 22, 2024

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJ-001-01-001US
  • KEYNOTE-F13 (Other Identifier: Merck Sharp & Dohme LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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