Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies

Prior treatment

• Ongoing immunosuppressive therapy, including systemic corticosteroids. Note: Subjects may be using topical or inhaled corticosteroids.
• Significant concurrent, uncontrolled medical condition
• Concurrent participation in another therapeutic treatment trial
• Prior treatment with CD74 targeting therapy

Other illness

• T-cell malignancy
• Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
• Clinically significant cardiac disease
• Known severe chronic obstructive pulmonary disease or asthma
• History of significant cerebrovascular disease
• Positive serology for hepatitis B defined by a positive test for HBsAg

Other

• Active plasma cell leukemia and/or leukemic manifestations of lymphoma
• Known amyloidosis (MM patients)
• Chronic lymphocytic leukemia and Richter's transformation, and prolymphocytic leukemia (NHL subjects)
• Sensory or motor neuropathy ≥ grade 2
• History or clinical signs of meningeal or active CNS involvement
• Known Human Immunodeficiency Virus seropositivity
• High screening liver function tests

• Confirmation of diagnosis
• Relapsed or relapsed/refractory disease
• Age ≥ 18 years
• ECOG performance status (0-2)
• Life expectancy \> 3 months
• Adequate bone marrow and renal functions
• QTcF \<500 msec
• Ability to comply with treatment, PK and test schedules
• NHL only- at least one measurable lesion