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

NCT06504368 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DCR-PDL1-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumors, Adult

Outcome Measures

Primary Outcomes (28)

• 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 Outcomes (2)

• 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

Study Arms (1)

DCR-PDL1

EXPERIMENTAL

Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle.

Drug: DCR-PDL1

Interventions

DCR-PDL1 DRUG

Solution for IV Infusion

DCR-PDL1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.

Sponsors & Collaborators

• Dicerna Pharmaceuticals, Inc., a Novo Nordisk company: lead

Study Sites (2)

NEXT Oncology

Irving, Texas, 75039, United States

RECRUITING

Next Oncology

San Antonio, Texas, 78229, United States

RECRUITING

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 16, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)