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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 and day 29 of cycle 1 (each cycle is 8 weeks)

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a new drug for people with cancer that has not responded to other treatments.

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.Check my eligibility

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.See study design

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 below

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My cancer is advanced and hasn't responded to standard treatments.

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My condition worsened after treatment that usually works.

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My cancer cannot be removed by surgery due to health reasons or because the tumor can't be surgically removed.

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I can care for myself and doctors expect me to live 3 months or more.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 29 of cycle 1 (each cycle is 8 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events and dose limiting toxicities

Severity of adverse events

Secondary outcome measures

Pharmacokinetic (AUC)

Pharmacokinetic (Urine)

Trial Design

1Treatment groups

Experimental Treatment

Group I: DCR-STAT3Experimental Treatment1 Intervention

DCR-STAT3

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyLead Sponsor

17 Previous Clinical Trials

533 Total Patients Enrolled

John Hanrahan, MD MPHStudy DirectorDicerna Phamaceuticals, a Novo Nordisk Company

1 Previous Clinical Trials

156 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide an assessment of the security associated with DCR-STAT3?

"Given the early stage of this trial, our team has assigned a score of 1 to DCR-STAT3's safety. This reflects that there is limited clinical evidence for both its efficacy and security profile."

Answered by AI

What is the participant count of this experiment?

"Affirmative. The clinicaltrials.gov record reveals that this research is presently recruiting patients, with 32 subjects required from 2 separate sites. This trial was first posted on August 14th 2023 and was most recently updated on October 21st 2023."

Answered by AI

Are participants still able to enroll in this experiment?

"Affirmative. As indicated by clinicaltrials.gov, this treatment trial opened recruitment on August 14th 2023 and was recentlyupdated on October 21st 2023. 32 individuals are needed to participate between two medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of DCR-STAT3 in Adults With Solid Tumors

2023. "A Study of DCR-STAT3 in Adults With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06098651.