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DCR-STAT3

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |Novo Nordisk A/S|Last Updated: Sep 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06098651A Study of DCR-STAT3 in Adults With Solid TumorsPHASE1 COMPLETED 26 — — Aug 14, 2023Sep 17, 2025Sep 29, 20252 United States
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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 — 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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