Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors

An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-PDL1 in Adults With Solid Tumors

The study will evaluate the safety, tolerability, and pharmacokinetics of intravenous DCR-PDL1 in adults with solid tumors. Participants will be enrolled in one of 4 ascending-dose cohorts. Each treatment cycle will consist of multiple intravenous (IV) doses. Dose escalation decisions will be based on data collected during the dose-limiting toxicity (DLT) period.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors, Adult
• Intervention / Treatment: Drug: DCR-PDL1

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• United States
  • Texas
    • Irving, Texas, United States, 75039
      • Recruiting
      • NEXT Oncology
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 for their condition OR
  • have demonstrated evidence of disease progression or relapse, via imaging, during or following standard therapy known to provide clinical benefit for their condition, OR
  • have demonstrated intolerance to standard therapy known to provide clinical benefit for their condition. OR
  • for which no standard therapy is available
• Measurable disease according to RECIST version 1.1.
• Malignancy not currently amenable to surgical intervention.
• ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months at the time of signing the informed consent.
• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.
• Other protocol defined exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCR-PDL1; Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle.	Drug: DCR-PDL1; Solution for IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.	Baseline up to week 8
Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure	Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.	Baseline up to week 8
Change From Baseline in Vital Signs: Pulse and Respiratory Rate	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.	Baseline up to week 8
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	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.	Baseline to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals	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.	Baseline to week 8
Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)	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.	Baseline to week 8
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	A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems.	Baseline to week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: DCR-PDL1-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No