Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 11:18 AM
Study NCT ID:
NCT06504368
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and Nature of Adverse Events (AEs)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Incidence of Dose-limiting Toxicities (DLTs)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature', 'timeFrame': 'Baseline up to week 8', 'description': 'Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.'}, {'measure': 'Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure', 'timeFrame': 'Baseline up to week 8', 'description': 'Vital signs will be measured in a semi-supine (i.e., semi-recumbent) position.'}, {'measure': 'Change From Baseline in Vital Signs: Pulse and Respiratory Rate', 'timeFrame': 'Baseline up to week 8', 'description': '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.'}, {'measure': 'Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in 12-lead Electrocardiogram (ECG): QRS intervals', 'timeFrame': 'Baseline to week 8', 'description': '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.'}, {'measure': 'Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals', 'timeFrame': 'Baseline to week 8', 'description': '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.'}, {'measure': 'Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)', 'timeFrame': 'Baseline to week 8', 'description': '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.'}, {'measure': 'Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Hematology Parameter: Mean corpuscular volume (MCV)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (MCH)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Hematology Parameter: Hemoglobin', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Hematology Parameter: Hematocrit and Mean corpuscular hemoglobin concentration (MCHC)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Coagulation Parameter: International normalized ratio (INR)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Coagulation Parameter: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Coagulation Parameter: Fibrinogen', 'timeFrame': 'Baseline to week 8'}, {'measure': '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)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Clinical Chemistry Parameter: Total protein and Albumin', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Clinical Chemistry Parameter: Total bilirubin, Direct bilirubin, Fasting blood glucose, Creatinine and Blood urea nitrogen (BUN)', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Clinical Chemistry Parameter: Sodium, Chloride and Potassium', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and Urobilinogen', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Urinalysis Parameter: Specific Gravity', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of Urine', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Urinalysis Parameter: Blood', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Urinalysis Parameter: Ketones and Nitrite', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Change from Baseline in Urinalysis Parameter: Leukocyte esterase', 'timeFrame': 'Baseline to week 8'}, {'measure': 'Number of Participants with Change from Baseline in Physical Examination Findings: Cardiovascular, Respiratory, Gastrointestinal, and Neurological systems', 'timeFrame': 'Baseline to week 8', 'description': 'A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic Plasma Concentrations of DCR-PDL1', 'timeFrame': 'Pre-dose up to 48 hours post-dose'}, {'measure': 'Pharmacokinetic Urine Concentrations of DCR-PDL1', 'timeFrame': 'Up to 8 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumors, Adult']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female adults, aged greater than or equal to (≥) 18 years.\n* Participants are required to have a documented, locally advanced or metastatic solid tumor malignancy, or non-Hodgkin's lymphoma\n\n * that is refractory to standard therapy known to provide clinical benefit for their condition OR\n * have demonstrated evidence of disease progression or relapse, via imaging, during or following standard therapy known to provide clinical benefit for their condition, OR\n * have demonstrated intolerance to standard therapy known to provide clinical benefit for their condition. OR\n * for which no standard therapy is available\n* Measurable disease according to RECIST version 1.1.\n* Malignancy not currently amenable to surgical intervention.\n* ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months at the time of signing the informed consent.\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.\n* Other protocol defined exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT06504368', 'briefTitle': 'Safety, Tolerability, and Pharmacokinetics of DCR-PDL1 in Adults With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous DCR-PDL1 in Adults With Solid Tumors', 'orgStudyIdInfo': {'id': 'DCR-PDL1-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DCR-PDL1', 'description': 'Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle.', 'interventionNames': ['Drug: DCR-PDL1']}], 'interventions': [{'name': 'DCR-PDL1', 'type': 'DRUG', 'description': 'Solution for IV Infusion', 'armGroupLabels': ['DCR-PDL1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75039', 'city': 'Irving', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Next Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Novo Nordisk', 'role': 'CONTACT', 'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178'}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dicerna Pharmaceuticals, Inc., a Novo Nordisk company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}