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RNAi Therapeutics
DCR-STAT3 for Cancer
Phase 1
Recruiting
Research Sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Long-term immunosuppressive therapy
Requirement for palliative radiotherapy to lesions that are defined as target lesions by RECIST version 1.1 criteria at the time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 29 of cycle 1 (each cycle is 8 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called DCR-STAT3 in adults with hard-to-treat solid tumors. The drug aims to block a protein that helps cancer grow, potentially shrinking the tumors or stopping their growth. Another compound, OPB-31121, is also being studied for its effects on the same protein.
Who is the study for?
Adults over 18 with advanced solid tumors or non-Hodgkin's lymphoma that can't be surgically removed and haven't responded to standard treatments. Participants must not be pregnant, agree to contraception, have a life expectancy of at least 3 months, and an ECOG status of 0-2 (able to perform daily activities). They cannot join if they've had certain recent treatments or are HIV/HBV/HCV positive.
What is being tested?
The trial is testing DCR-STAT3, a new drug for people with solid tumors that no longer respond to usual treatment. It's given in increasing doses to check its safety and how the body processes it. The study will gradually enroll more patients as it confirms lower doses are safe.
What are the potential side effects?
Potential side effects of DCR-STAT3 may include typical reactions seen with cancer therapies such as fatigue, nausea, inflammation-related symptoms but specific side effects will be monitored due to the novel nature of this therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and hasn't responded to standard treatments.
Select...
My condition worsened after treatment that usually works.
Select...
My cancer cannot be removed by surgery due to health reasons or because the tumor can't be surgically removed.
Select...
I can care for myself and doctors expect me to live 3 months or more.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on long-term medication to suppress my immune system.
Select...
I need targeted radiation for specific cancer lesions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and day 29 of cycle 1 (each cycle is 8 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 29 of cycle 1 (each cycle is 8 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events and dose limiting toxicities
Severity of adverse events
Secondary study objectives
Pharmacokinetic (AUC)
Pharmacokinetic (Urine)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DCR-STAT3Experimental Treatment1 Intervention
DCR-STAT3
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The inhibition of the STAT3 pathway, as studied in the DCR-STAT3 trial, targets a key signaling molecule involved in tumor growth and survival. STAT3 is often overactive in solid tumors, promoting cancer cell proliferation, survival, and immune evasion.
By inhibiting STAT3, treatments aim to reduce tumor growth and enhance the immune system's ability to fight cancer. Other common treatments for solid tumors include chemotherapy, which kills rapidly dividing cells; targeted therapy, which blocks specific molecules involved in cancer growth; and immunotherapy, which boosts the body's immune response against cancer cells.
These treatments are crucial for managing solid tumors as they address different aspects of tumor biology and can be tailored to individual patient needs.
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Who is running the clinical trial?
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyLead Sponsor
18 Previous Clinical Trials
535 Total Patients Enrolled
John Hanrahan, MD MPHStudy DirectorDicerna Phamaceuticals, a Novo Nordisk Company
1 Previous Clinical Trials
156 Total Patients Enrolled
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