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NCT Number: NCT06504368

Safety, Tolerability, and Pharmacokinetics of 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.

Recruiting

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Key information

Conditions

Solid Tumors, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NEXT Oncology, Irving, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DCR-PDL1

Drug

Solution for IV Infusion

Primary outcomes

  1. Incidence and Nature of Adverse Events (AEs)

    Time frame: Baseline to week 8

  2. Incidence of Dose-limiting Toxicities (DLTs)

    Time frame: Baseline to week 8

  3. Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature

    Time frame: Baseline up to week 8

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

  4. Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure

    Time frame: Baseline up to week 8

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

  5. Change From Baseline in Vital Signs: Pulse and Respiratory Rate

    Time frame: 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.

  6. Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate

    Time frame: Baseline to week 8

  7. Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  10. Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes

    Time frame: Baseline to week 8

  11. Change from Baseline in Hematology Parameter: Mean corpuscular volume (MCV)

    Time frame: Baseline to week 8

  12. Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (MCH)

    Time frame: Baseline to week 8

  13. Change from Baseline in Hematology Parameter: Hemoglobin

    Time frame: Baseline to week 8

  14. Change from Baseline in Hematology Parameter: Hematocrit and Mean corpuscular hemoglobin concentration (MCHC)

    Time frame: Baseline to week 8

  15. Change from Baseline in Coagulation Parameter: International normalized ratio (INR)

    Time frame: Baseline to week 8

  16. Change from Baseline in Coagulation Parameter: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT)

    Time frame: Baseline to week 8

  17. Change from Baseline in Coagulation Parameter: Fibrinogen

    Time frame: Baseline to week 8

  18. 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)

    Time frame: Baseline to week 8

  19. Change from Baseline in Clinical Chemistry Parameter: Total protein and Albumin

    Time frame: Baseline to week 8

  20. Change from Baseline in Clinical Chemistry Parameter: Total bilirubin, Direct bilirubin, Fasting blood glucose, Creatinine and Blood urea nitrogen (BUN)

    Time frame: Baseline to week 8

  21. Change from Baseline in Clinical Chemistry Parameter: Sodium, Chloride and Potassium

    Time frame: Baseline to week 8

  22. Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and Urobilinogen

    Time frame: Baseline to week 8

  23. Change from Baseline in Urinalysis Parameter: Specific Gravity

    Time frame: Baseline to week 8

  24. Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of Urine

    Time frame: Baseline to week 8

  25. Change from Baseline in Urinalysis Parameter: Blood

    Time frame: Baseline to week 8

  26. Change from Baseline in Urinalysis Parameter: Ketones and Nitrite

    Time frame: Baseline to week 8

  27. Change from Baseline in Urinalysis Parameter: Leukocyte esterase

    Time frame: Baseline to week 8

  28. Number of Participants with Change from Baseline in Physical Examination Findings: Cardiovascular, Respiratory, Gastrointestinal, and Neurological systems

    Time frame: Baseline to week 8

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

Secondary outcomes

  1. Pharmacokinetic Plasma Concentrations of DCR-PDL1

    Time frame: Pre-dose up to 48 hours post-dose

  2. Pharmacokinetic Urine Concentrations of DCR-PDL1

    Time frame: Up to 8 hours post-dose

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 16, 2024
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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