A Study of DCR-STAT3 in Adults With Solid Tumors

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.

Conditions

Solid Tumor, Adult, Refractory Tumor

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Study Overview

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Study Details

Study overview

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.

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

A Study of DCR-STAT3 in Adults With Solid Tumors

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Dallas

Next Oncology, Dallas, Texas, United States, 75039

San Antonio

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age
  • * ≥ 18 years of age inclusive, at the time of signing the informed consent.
  • * 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
  • 1. Refrain from donating sperm
  • 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
  • 3. Must agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant
  • 1. Is not a WOCBP OR
  • 2. Is a WOCBP and:
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company,

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

Study Record Dates

2025-07-01