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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

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

DCR-PDL1 · 1 trial · 1 indication

Phase 1 1
NCT06504368Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid TumorsSolid Tumors, Adult
RECRUITING32 Analytics
PHASE1RECRUITING
Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors
Solid Tumors, Adult
NCT0650436832
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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 to 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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Frequently asked questions about DCR-PDL1

What is DCR-PDL1 used for?

DCR-PDL1 is an investigational small molecule being developed for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and its safety and efficacy are still being evaluated in clinical trials.

What does DCR-PDL1 target?

DCR-PDL1 is designed to target PD-L1, a protein involved in immune regulation. By targeting PD-L1, the drug aims to modulate the immune response against tumor cells. This mechanism is being studied in the context of solid tumors, where PD-L1 expression can help tumors evade immune detection.

Who makes DCR-PDL1?

DCR-PDL1 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in adult patients with solid tumors.

What phase is DCR-PDL1 in?

DCR-PDL1 is currently in Phase 1 clinical development. This is an early stage of testing that focuses on assessing the drug's safety, tolerability, and how it is processed by the body. The drug is investigational and has not yet been approved for use outside of clinical trials.

What clinical trials is DCR-PDL1 in?

DCR-PDL1 is being studied in a Phase 1 clinical trial registered as NCT06504368. This trial is titled 'Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors' and is currently recruiting participants in the United States. The study aims to enroll 32 adult patients with solid tumors.

Is DCR-PDL1 the same as PD-L1 inhibitors?

DCR-PDL1 is a small molecule designed to target PD-L1, similar in concept to other PD-L1 inhibitors used in oncology. However, it is a distinct investigational drug developed by Novo Nordisk. Its specific chemical structure and properties differentiate it from other agents in this class, and it is still in early clinical testing.