A Study of DCR-STAT3 in Adults With Solid Tumors

NCT06098651 | Completed Phase 1 FDA Drug

• 1 other identifier: DCR-STAT3-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events and dose limiting toxicities

  safety and tolerability

  Cycle 1 (8 weeks)

• Severity of adverse events

  measured according to CTCAE 5.0 criteria

  Cycle 1 (8 weeks)

Secondary Outcomes (2)

• Pharmacokinetic (AUC)

  Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)

• Pharmacokinetic (Urine)

  Day 1 and Day 29 of Cycle 1 (each cycle is 8 weeks)

Study Arms (1)

DCR-STAT3

EXPERIMENTAL

DCR-STAT3

Drug: DCR-STAT3

Interventions

DCR-STAT3 DRUG

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.

DCR-STAT3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dicerna Pharmaceuticals, Inc., a Novo Nordisk company: lead

Study Sites (2)

Next Oncology

Dallas, Texas, 75039, United States

Location

Next Oncology

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• John Hanrahan, MD MPH

  Dicerna Phamaceuticals, a Novo Nordisk Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. Participants will be enrolled across 4 ascending-dose cohorts. Each treatment cycle will consist of multiple IV doses. Dose escalation decisions will be evaluated in conjunction with a Safety Review Committee (SRC). The study will be conducted over 4 dose cohorts in a 3+3 design and will initially comprise 12 to 24 participants. Should one DLT occur within a given cohort, an additional 3 participants will be enrolled in that cohort. Two cohorts will be backfilled or expanded to a total of at least 10 participants in each cohort, for a total enrollment of approximately 32 participants. The cohorts and associated dose levels will be chosen in a data-driven fashion as the study proceeds, in conjunction with the SRC.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 24, 2023
• Study Start: August 14, 2023
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)