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DCR-PDL1

Phase 1

Solid Tumors, Adult | Small molecule | Oncology |Novo Nordisk A/S|Last Updated: Nov 6, 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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06504368Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid TumorsPHASE1 RECRUITING 32 — — May 29, 2024Dec 31, 2027Nov 6, 20252 United States
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Study Endpoints
Primary Endpoints
Incidence and Nature of Adverse Events (AEs)
Baseline to week 8
Incidence of Dose-limiting Toxicities (DLTs)
Baseline to week 8
Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature
Baseline up to week 8

Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.

Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure
Baseline up to week 8

Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.

Change From Baseline in Vital Signs: Pulse and Respiratory Rate
Baseline up to week 8

Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position. Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate
Baseline to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals
Baseline to week 8

ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals
Baseline to week 8

ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)
Baseline to week 8

ECG recordings will be made in a semi-supine (i.e., semi-recumbent) position, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.

Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes
Baseline to week 8
Change from Baseline in Hematology Parameter: Mean corpuscular volume (MCV)
Baseline to week 8
Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (MCH)
Baseline to week 8
Change from Baseline in Hematology Parameter: Hemoglobin
Baseline to week 8
Change from Baseline in Hematology Parameter: Hematocrit and Mean corpuscular hemoglobin concentration (MCHC)
Baseline to week 8
Change from Baseline in Coagulation Parameter: International normalized ratio (INR)
Baseline to week 8
Change from Baseline in Coagulation Parameter: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT)
Baseline to week 8
Change from Baseline in Coagulation Parameter: Fibrinogen
Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP), Lactate dehydrogenase (LDH) and Creatine kinase (CK)
Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Total protein and Albumin
Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Total bilirubin, Direct bilirubin, Fasting blood glucose, Creatinine and Blood urea nitrogen (BUN)
Baseline to week 8
Change from Baseline in Clinical Chemistry Parameter: Sodium, Chloride and Potassium
Baseline to week 8
Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and Urobilinogen
Baseline to week 8
Change from Baseline in Urinalysis Parameter: Specific Gravity
Baseline to week 8
Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of Urine
Baseline to week 8
Change from Baseline in Urinalysis Parameter: Blood
Baseline to week 8
Change from Baseline in Urinalysis Parameter: Ketones and Nitrite
Baseline to week 8
Change from Baseline in Urinalysis Parameter: Leukocyte esterase
Baseline to week 8
Number of Participants with Change from Baseline in Physical Examination Findings: Cardiovascular, Respiratory, Gastrointestinal, and Neurological systems
Baseline to week 8

A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems.

Secondary Endpoints
Pharmacokinetic Plasma Concentrations of DCR-PDL1
Pre-dose up to 48 hours post-dose
Pharmacokinetic Urine Concentrations of DCR-PDL1
Up to 8 hours post-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DCR-PDL1EXPERIMENTALParticipants will receive multiple IV doses of DCR-PDL1 during each treatment cycle.
Interventions
NameTypeDescription
DCR-PDL1DRUGSolution for IV Infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female adults, aged greater than or equal to (≥) 18 years. * Participants are required to have a documented, locally advanced or metastatic solid tumor malignancy, or non-Hodgkin's lymphoma * that is refractory to standard therapy known to provide clinical benefit f...

Countries:United States
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