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?

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

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