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IONIS-STAT3Rx

Phase 1

Advanced Cancers | Small molecule | Oncology |Ionis Pharmaceuticals, Inc.|Last Updated: Jun 25, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

IONIS-STAT3Rx · 1 trial · 3 indications

Phase 1 1
NCT01563302Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced CancersAdvanced Cancers
COMPLETED64 Analytics
PHASE1COMPLETED
Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers
Advanced CancersUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Clinical activity of IONIS-STAT3Rx
Approximately 28 Days after last dose of IONIS-STAT3Rx
Pharmacokinetics-Cmax
Approximately 28 days after last dose of IONIS-STAT3Rx
STAT3 and other biomarkers
Approximately 28 days after last dose of IONIS-STAT3Rx
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALIONIS-STAT3Rx

Interventions

NameTypeDescription
IONIS-STAT3RxDRUGThree-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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 RECIS...

Countries:United States
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Frequently asked questions about IONIS-STAT3Rx

What is IONIS-STAT3Rx used for?

IONIS-STAT3Rx is an investigational drug being developed for the treatment of advanced cancers, including diffuse large B-cell lymphoma (DLBCL) and lymphoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does IONIS-STAT3Rx target?

IONIS-STAT3Rx is a small molecule designed to target STAT3, a protein involved in cancer cell growth and survival. By inhibiting STAT3, the drug aims to disrupt signaling pathways that promote tumor progression in advanced cancers.

Who makes IONIS-STAT3Rx?

IONIS-STAT3Rx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced cancers.

What phase is IONIS-STAT3Rx in?

IONIS-STAT3Rx is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in an early-stage trial to assess its safety, tolerability, and dosing in patients with advanced cancers.

What clinical trials is IONIS-STAT3Rx in?

IONIS-STAT3Rx has one completed clinical trial, NCT01563302, a Phase 1/2 open-label, dose-escalation study in patients with advanced cancers, including DLBCL and lymphoma. The trial enrolled 64 participants in the United States and was not randomized or blinded.