Status:
UNKNOWN
Safety Study of BJ-001, an IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors
Lead Sponsor:
BJ Bioscience, Inc.
Collaborating Sponsors:
PPD Development, LP
Merck Sharp & Dohme LLC
Conditions:
Locally Advanced/Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pembroli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 22 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04294576
Start Date
December 4 2019
End Date
October 22 2024
Last Update
November 9 2023
Active Locations (5)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
Mount Sinai
New York, New York, United States, 10029
3
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States, 29605
4
NEXT Oncology
San Antonio, Texas, United States, 78229