- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06098651
A Study of DCR-STAT3 in Adults With Solid Tumors
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Vinita Uttamsingh
- Phone Number: 857-278-9860
- Email: VIUT@novonordisk.com
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75039
- Recruiting
- Next Oncology
-
Contact:
- Shiraj Sen, MD PHD
- Phone Number: 972-893-8800
-
San Antonio, Texas, United States, 78229
- Recruiting
- Next Oncology
-
Contact:
- Anthony Tolcher, MD
- Phone Number: 210-580-9500
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age
- ≥ 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
Weight
- BMI ≥ 18 kg/m2
Sex
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:
Refrain from donating sperm
AND, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
- Must agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant
Female participants are eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:
- Is not a WOCBP OR
Is a WOCBP and:
is using a contraceptive method that is highly effective, with a failure rate of < 1%, as described in Section 10.4 during the study intervention period and for at least 24 weeks after the last dose of study intervention. The Investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
must have a negative highly sensitive pregnancy test (serum as required by local regulations) on Day 1 of each cycle before the first 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DCR-STAT3
|
DCR-STAT3 is a sterile, preservative-free solution in WFI that will be diluted in a suitable admixture diluent (0.9% normal saline) prior to IV infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events and dose limiting toxicities
Time Frame: Cycle 1 (8 weeks)
|
safety and tolerability
|
Cycle 1 (8 weeks)
|
Severity of adverse events
Time Frame: Cycle 1 (8 weeks)
|
measured according to CTCAE 5.0 criteria
|
Cycle 1 (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic (AUC)
Time Frame: Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
|
Area under the plasma concentration versus time curve
|
Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
|
Pharmacokinetic (Urine)
Time Frame: Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
|
Urinary excretion
|
Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)
|
Collaborators and Investigators
Investigators
- Study Director: John Hanrahan, MD MPH, Dicerna Phamaceuticals, a Novo Nordisk Company
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCR-STAT3-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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