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

Status unconfirmed · Phase 1

Conditions studied: Locally Advanced/Metastatic Solid Tumors

In brief

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

Key facts

Study ID

NCT04294576

Run by

BJ Bioscience, Inc.

People needed

92

Starts

2019-12-04

Expected to finish

2024-10-22

Last updated by the study team

2023-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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