Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers

A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers

This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.

Inclusion Criteria:

• Aged 18 years or older
• Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists
• Expansion cohort only: Advanced lymphoma confirmed by histopathology
• Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors
• ECOG Performance Status less than or equal to 2
• Life expectancy greater than 12 weeks in the opinion of the Investigator

Exclusion Criteria:

• Any active or uncontrolled infection
• NYHA Grade II or greater congestive heart failure
• History of myocardial infarction within 6 months prior to screening
• Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter