Clinical trial · Interventional
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
NCT01563302CI-TRIAL-00033411completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IONIS-STAT3Rx | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- IONIS-STAT3Rx
- interventionNames
- Drug: IONIS-STAT3Rx
Primary outcomes (2)
- measure
- Safety of IONIS-STAT3Rx in patients with Advanced Cancers
- timeFrame
- Approximately 28 days after last dose of IONIS -STAT3Rx
- measure
- Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.
- timeFrame
- Approximately 28 Days
- description
- Highest dose level at which no more than 1 out of 6 patients develops a DLT
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDReilley MJ, McCoon P, Cook C, Lyne P, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Curran M, Liu Q, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MVP, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR, Hong DS. STAT3 antisense oligonucleotide AZD9150 in a subset of patients with heavily pretreated lymphoma: results of a phase 1b trial. J Immunother Cancer. 2018 Nov 16;6(1):119. doi: 10.1186/s40425-018-0436-5. PMID 30446007