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DCR-STAT3

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |Novo Nordisk A/S|Trials Updated: Sep 29, 2026

DCR-STAT3 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

DCR-STAT3 clinical trials

DCR-STAT3 · 1 trial · 2 indications

Phase 1 1
NCT06098651A Study of DCR-STAT3 in Adults With Solid TumorsSolid Tumor, Adult
COMPLETED26 Analytics
PHASE1COMPLETED
A Study of DCR-STAT3 in Adults With Solid Tumors
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events and dose limiting toxicities
Cycle 1 (8 weeks)

safety and tolerability

Severity of adverse events
Cycle 1 (8 weeks)

measured according to CTCAE 5.0 criteria

Secondary Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DCR-STAT3EXPERIMENTALDCR-STAT3

Interventions

NameTypeDescription
DCR-STAT3DRUGDCR-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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * 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 provi...

Countries:United States
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Frequently asked questions about DCR-STAT3

What is DCR-STAT3 used for?

DCR-STAT3 is an investigational small molecule being studied for the treatment of adults with solid tumors, including refractory tumors. It is being developed by Novo Nordisk A/S as an oncology therapeutic. It is not approved for any indication and remains in clinical development.

Who is developing DCR-STAT3?

DCR-STAT3 is being developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is the sponsor of the clinical program evaluating the small molecule in adult patients with solid tumors.

What phase is DCR-STAT3 in?

DCR-STAT3 is in Phase 1 clinical development. The program has completed one Phase 1 trial in adults with solid tumors. No Phase 2 or later studies have been reported, and the drug is not approved for any indication.

What clinical trials is DCR-STAT3 in?

DCR-STAT3 has been evaluated in one clinical trial, NCT06098651, titled A Study of DCR-STAT3 in Adults With Solid Tumors. The Phase 1 trial enrolled 26 participants in the United States and is listed as completed. It was an uncontrolled study without randomization or blinding.

Is DCR-STAT3 FDA approved?

No. DCR-STAT3 is an investigational small molecule in Phase 1 clinical development and is not approved by the FDA for any indication. Its only reported trial, NCT06098651, has completed, and further clinical evaluation would be required before any regulatory review.