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

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)

1. 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
2. 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.

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

Exclusion Criteria:

1. Pregnant or nursing females.
2. 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).
3. 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,
4. Patients with a history of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity.
5. Patients with a history of pneumonitis, myocarditis, history of Stevens-Johnson syndrome or toxic epidermal necrolysis.
6. Patients who have undergone a bone marrow transplantation, solid organ transplantation, or stem cell transplant.
7. Patients with unresolved AEs > Grade 1 from prior anticancer therapy.
8. Patients who have received prior interferon or IL-2 therapy less than 4 weeks prior to enrollment.
9. Uncontrolled primary central nervous system (CNS) tumors or CNS metastases; based on screening.
10. Patients with active autoimmune disease or a documented medical history of autoimmune disease managed by replacement therapy.