[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06504368":3,"trial-entities:NCT06504368":153,"trial-summary:NCT06504368":158},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":97,"sex":104,"minimum_age":105,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":106,"std_ages":120,"locations":123,"central_contacts":140,"overall_officials":146,"references":151,"see_also_links":152},"NCT06504368","DCR-PDL1-101","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","RECRUITING","2027-12-31","2025-11","2025-11-06","2024-05-29","Dicerna Pharmaceuticals, Inc., a Novo Nordisk company","INDUSTRY",false,"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.",null,[19],"Solid Tumors, Adult",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},32,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","DCR-PDL1","Solution for IV Infusion",[31],[35,38,40,44,46,49,51,54,56,58,60,62,64,66,68,70,72,74,76,78,80,82,84,86,88,90,92,94],{"measure":36,"timeFrame":37},"Incidence and Nature of Adverse Events (AEs)","Baseline to week 8",{"measure":39,"timeFrame":37},"Incidence of Dose-limiting Toxicities (DLTs)",{"measure":41,"description":42,"timeFrame":43},"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",{"measure":45,"description":42,"timeFrame":43},"Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure",{"measure":47,"description":48,"timeFrame":43},"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.",{"measure":50,"timeFrame":37},"Change from Baseline in 12-lead Electrocardiogram (ECG): Heart Rate and Pulse Rate",{"measure":52,"description":53,"timeFrame":37},"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.",{"measure":55,"description":53,"timeFrame":37},"Change from Baseline in 12-lead Electrocardiogram (ECG): QT intervals",{"measure":57,"description":53,"timeFrame":37},"Change from Baseline in 12-lead Electrocardiogram (ECG): QTcF intervals (QT Interval Corrected by the Fridericia Formula)",{"measure":59,"timeFrame":37},"Change from Baseline in Hematology Parameter: Red blood cells, White blood cells, Lymphocytes, Monocytes, Eosinophils, Neutrophils, Basophils and Platelets, Reticulocytes",{"measure":61,"timeFrame":37},"Change from Baseline in Hematology Parameter: Mean corpuscular volume (MCV)",{"measure":63,"timeFrame":37},"Change from Baseline in Hematology Parameter: Mean corpuscular hemoglobin (MCH)",{"measure":65,"timeFrame":37},"Change from Baseline in Hematology Parameter: Hemoglobin",{"measure":67,"timeFrame":37},"Change from Baseline in Hematology Parameter: Hematocrit and Mean corpuscular hemoglobin concentration (MCHC)",{"measure":69,"timeFrame":37},"Change from Baseline in Coagulation Parameter: International normalized ratio (INR)",{"measure":71,"timeFrame":37},"Change from Baseline in Coagulation Parameter: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT)",{"measure":73,"timeFrame":37},"Change from Baseline in Coagulation Parameter: Fibrinogen",{"measure":75,"timeFrame":37},"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)",{"measure":77,"timeFrame":37},"Change from Baseline in Clinical Chemistry Parameter: Total protein and Albumin",{"measure":79,"timeFrame":37},"Change from Baseline in Clinical Chemistry Parameter: Total bilirubin, Direct bilirubin, Fasting blood glucose, Creatinine and Blood urea nitrogen (BUN)",{"measure":81,"timeFrame":37},"Change from Baseline in Clinical Chemistry Parameter: Sodium, Chloride and Potassium",{"measure":83,"timeFrame":37},"Change from Baseline in Urinalysis Parameter: Glucose, Protein, Bilirubin and Urobilinogen",{"measure":85,"timeFrame":37},"Change from Baseline in Urinalysis Parameter: Specific Gravity",{"measure":87,"timeFrame":37},"Change from Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) of Urine",{"measure":89,"timeFrame":37},"Change from Baseline in Urinalysis Parameter: Blood",{"measure":91,"timeFrame":37},"Change from Baseline in Urinalysis Parameter: Ketones and Nitrite",{"measure":93,"timeFrame":37},"Change from Baseline in Urinalysis Parameter: Leukocyte esterase",{"measure":95,"description":96,"timeFrame":37},"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.",[98,101],{"measure":99,"timeFrame":100},"Pharmacokinetic Plasma Concentrations of DCR-PDL1","Pre-dose up to 48 hours post-dose",{"measure":102,"timeFrame":103},"Pharmacokinetic Urine Concentrations of DCR-PDL1","Up to 8 hours post-dose","ALL","18 Years",{"inclusion":107,"exclusion":117,"raw_text":119},[108,109,110,111,112,113,114,115,116],"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.",[118],"Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required.","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",[121,122],"ADULT","OLDER_ADULT",[124,133],{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":129,"geoPoint":130},"NEXT Oncology","Irving","Texas","75039","United States",{"lat":131,"lon":132},32.81402,-96.94889,{"facility":134,"status":8,"city":135,"state":127,"zip":136,"country":129,"geoPoint":137},"Next Oncology","San Antonio","78229",{"lat":138,"lon":139},29.42412,-98.49363,[141],{"name":142,"role":143,"phone":144,"email":145},"Novo Nordisk","CONTACT","(+1) 866-867-7178","clinicaltrials@novonordisk.com",[147],{"name":148,"affiliation":149,"role":150},"Clinical Transparency (dept. 2834)","Novo Nordisk A\u002FS","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":154,"biomarkers":157},[155,156],"Non-Hodgkin Lymphoma","Solid Neoplasm",[],{"nct_id":4,"found":159,"summary":160,"prompt_version":170},true,{"design":161,"status":162,"heading":163,"summary":164,"follow_up":165,"word_count":166,"commitments":167,"compensation":168,"drugs_mentioned":169},"This is an interventional study, meaning participants will receive a specific treatment. It involves 32 participants and will test increasing doses of DCR-PDL1 in different groups.","completed","DCR-PDL1 for Advanced Solid Tumors","This study is testing a drug called DCR-PDL1 given through an IV (intravenous, into a vein) to adults with advanced solid tumors or non-Hodgkin's lymphoma. These are cancers that have either not responded to standard treatments or have come back. The main goals are to see how safe DCR-PDL1 is, how well your body tolerates it, and how your body processes the drug. You would be part of a group receiving different doses of DCR-PDL1, starting with lower doses and gradually increasing. The study aims to enroll 32 participants.","Your safety, including adverse events (side effects) and vital signs, will be monitored from the start of treatment up to 8 weeks.",89,"You would receive multiple intravenous doses of DCR-PDL1 in treatment cycles. Safety and vital signs will be monitored from the start of treatment up to 8 weeks.","Not stated in the trial record.",[31],"v2"]