COMPLETED

A Study of DCR-STAT3 in Adults With Solid Tumors

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Conditions

Solid Tumor, AdultRefractory Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-14
Study Completion:2025-09-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06098651

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age
  2. * ≥ 18 years of age inclusive, at the time of signing the informed consent.
  3. * Demonstrated evidence of disease progression, via imaging, during or following standard therapy known to provide clinical benefit for their condition
  4. * Demonstrated intolerance to standard therapy known to provide clinical benefit for their condition
  5. * Measurable disease according to RECIST version 1.1 (as determined by CT or MRI)
  6. * Malignancy not currently amenable to surgical intervention due to medical contraindication or non-resectability of the tumor
  7. * ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months
  8. 1. Refrain from donating sperm
  9. 2. 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
  10. 3. Must agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant
  11. 1. Is not a WOCBP OR
  12. 2. Is a WOCBP and:
  1. * Continued compromise or inadequate recovery from a prior anti-neoplastic therapy
  2. * Known hypersensitivity to any of the components of DCR-STAT3
  3. * Long-term immunosuppressive therapy
  4. * 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

Contacts and Locations

Principal Investigator

John Hanrahan, MD MPH
STUDY_DIRECTOR
Dicerna Phamaceuticals, a Novo Nordisk Company

Study Locations (Sites)

Next Oncology
Dallas, Texas, 75039
United States
Next Oncology
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

  • John Hanrahan, MD MPH, STUDY_DIRECTOR, Dicerna Phamaceuticals, a Novo Nordisk Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-14
Study Completion Date2025-09-17

Study Record Updates

Study Start Date2023-08-14
Study Completion Date2025-09-17

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor, Adult
  • Refractory Tumor