Advanced Cancers, DLBCL, Lymphoma
Conditions
Keywords
Advanced Cancers, DLBCL, Advanced Lymphoma
Brief summary
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.
Interventions
DRUGIONIS-STAT3Rx
Three-hour IV infusions on Cycle 0 Days 1, 3, 5, and weekly three-hour IV infusions in Cycles 1 and beyond, on Days 1, 8, and 15 of each cycle.
Sponsors
AstraZeneca
Ionis Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of IONIS-STAT3Rx in patients with Advanced Cancers | Approximately 28 days after last dose of IONIS -STAT3Rx | — |
| Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers. | Approximately 28 Days | Highest dose level at which no more than 1 out of 6 patients develops a DLT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical activity of IONIS-STAT3Rx | Approximately 28 Days after last dose of IONIS-STAT3Rx | Measured by RECIST in the study population who have measurable disease or relevant disease specific response criteria |
| Pharmacokinetics-Cmax | Approximately 28 days after last dose of IONIS-STAT3Rx | Maximum observed drug concentration (Cmax) |
| STAT3 and other biomarkers | Approximately 28 days after last dose of IONIS-STAT3Rx | The effect of treatment with IONIS-STAT3Rx on phospho-STAT3 and other biomarkers |
| Pharmacokinetics - Tmax | Approximately 28 days after last dose of IONIS-STAT3Rx | Time taken to reach Cmax |
Countries
United States
Outcome results
None listed