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

Ionis Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lymphoma; DLBCL; Advanced Cancers

Treatments: Drug: IONIS-STAT3Rx

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563302

ISIS 481464-CS1

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Group 1

Experimental group

Description:

IONIS-STAT3Rx

Treatment:

Drug: IONIS-STAT3Rx