A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers
Rochester, Minn., Phoenix/Scottsdale, Ariz.
Trial status: Open for Enrollment
Why is this study being done?
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.
Who is eligible to participate?
- 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
- 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