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

Phase 1RecruitingNCT06504368

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors, Adult

Interventions

DCR-PDL1DRUG

Solution for IV Infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

NEXT Oncology

Irving, Texas, United States

RECRUITING

Next Oncology

San Antonio, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence and Nature of Adverse Events (AEs)

Time frame: Baseline to week 8

Incidence of Dose-limiting Toxicities (DLTs)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline up to week 8

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

Time frame: 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.

Time frame: 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.

Central Contacts

Novo Nordisk

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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.

Time frame: Baseline to week 8

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

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

Time frame: Baseline to week 8

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

Time frame: Baseline to week 8

Change from Baseline in Hematology Parameter: Hemoglobin

Time frame: Baseline to week 8

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

Time frame: Baseline to week 8

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

Time frame: Baseline to week 8

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

Time frame: Baseline to week 8

Change from Baseline in Coagulation Parameter: Fibrinogen

Time frame: 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)

Time frame: Baseline to week 8

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

Time frame: Baseline to week 8

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

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

Time frame: Baseline to week 8

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

Time frame: Baseline to week 8

Change from Baseline in Urinalysis Parameter: Specific Gravity

Time frame: Baseline to week 8

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

Time frame: Baseline to week 8

Change from Baseline in Urinalysis Parameter: Blood

Time frame: Baseline to week 8

Change from Baseline in Urinalysis Parameter: Ketones and Nitrite

Time frame: Baseline to week 8

Change from Baseline in Urinalysis Parameter: Leukocyte esterase

Time frame: 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.

Time frame: Baseline to week 8

Secondary Outcomes

Pharmacokinetic Plasma Concentrations of DCR-PDL1

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

Pharmacokinetic Urine Concentrations of DCR-PDL1

Time frame: Up to 8 hours post-dose