An Open-label, Phase 1, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-STAT3 in Adults With Refractory Solid Tumors

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company1 site in 1 country26 target enrollmentAugust 14, 2023

ConditionsSolid Tumor, Adult Refractory Tumor

InterventionsDCR-STAT3

DrugsDCR-STAT3

Overview

Phase: Phase 1
Intervention: DCR-STAT3
Conditions: Solid Tumor, Adult
Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Enrollment: 26
Locations: 1
Primary Endpoint: Severity of adverse events
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a sequential, ascending-dose, multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety, tolerability, and pharmacokinetics of DCR-STAT3.

Detailed Description

The primary goal of this first-in-human study is to assess the safety and tolerability of DCR-STAT3 in adults with refractory solid tumors. Secondary study goals are to evaluate potential antitumor effects of STAT3 knockdown, as assessed by circulating blood biomarkers indicative of immune activation, as well as any direct impact on tumor size by appropriate imaging and RECIST 1.1 criteria. Antitumor effects will be evaluated for DCR-STAT3 as a monotherapy.

Registry

clinicaltrials.gov

Start Date

August 14, 2023

End Date

September 17, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥ 18 years of age inclusive, at the time of signing the informed consent.
•Type of Participant and Disease Characteristics
•\- Documented locally advanced or metastatic solid tumor malignancy or non-Hodgkin's lymphoma that is refractory to standard therapy known to provide clinical benefit for their condition or for which no standard therapy is available
•Demonstrated evidence of disease progression, via imaging, during or following standard therapy known to provide clinical benefit for their condition
•Demonstrated intolerance to standard therapy known to provide clinical benefit for their condition
•Measurable disease according to RECIST version 1.1 (as determined by CT or MRI)
•Malignancy not currently amenable to surgical intervention due to medical contraindication or non-resectability of the tumor
•ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months
•\- BMI ≥ 18 kg/m2
•Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 24 weeks after the last dose of study intervention:

Exclusion Criteria

•Prior/Concomitant Therapy
•\- Other concurrent (within 28 days of Day 1, Cycle 1) chemotherapy, immunotherapy, or radiotherapy. Note that hormonal therapy (e.g., tamoxifen, LHRH agonists) is allowed.
•\- Requirement for palliative radiotherapy to lesions that are defined as target lesions by RECIST version 1.1 criteria at the time of study entry
•Continued compromise or inadequate recovery from a prior anti-neoplastic therapy
•Known hypersensitivity to any of the components of DCR-STAT3
•Long-term immunosuppressive therapy
•Prior/Concurrent Clinical Study Experience
•Treatment with investigational therapy(ies) within 5 half-lives of the investigational therapy prior to the first scheduled day of dosing with DCR-STAT3, or 4 weeks if the half-life of the investigational agent is not known
•Diagnostic assessments - Seropositive for antibodies to HIV, HBV, or HCV at Screening (historical testing may be used if performed within the 3 months prior to screening). NOTE: In participants with previous treatment for hepatitis C with direct-acting HCV medication and seropositivity for HCV, or in participants with prior infection and spontaneous resolution, HCV RNA must be undetectable (at least 2 negative HCV RNA tests at least 12 weeks apart), and the HCV infection must have been resolved or cured \> 3 years prior to initial dosing with the investigational medication.