Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 10:35 AM
Study NCT ID:
NCT06562192
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-01-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309', 'timeFrame': 'From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule', 'description': 'A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE (version 5.0) Grade 3 or higher that occurs within the DLT evaluation period and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with a few exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not Grade 3 or higher.'}, {'measure': 'Incidence and severity of adverse events and serious adverse events of [177Lu]Lu-NNS309', 'timeFrame': 'From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months', 'description': 'The distribution of adverse events will be done via the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) and through the monitoring of relevant clinical and laboratory safety parameters.'}, {'measure': 'Dose modifications for [177Lu]Lu-NNS309', 'timeFrame': 'From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks', 'description': 'Dose modifications (dose interruptions and reductions) for \\[177Lu\\]Lu-NNS309 will be assessed and summarized using descriptive statistics. The number of patients with dose modification will be summarized by treatment groups.'}, {'measure': 'Dose intensity for [177Lu]Lu-NNS309', 'timeFrame': 'From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks', 'description': 'Dose intensity for \\[177Lu\\]Lu-NNS309 will be assessed and summarized using descriptive statistics. Dose intensity is computed as the ratio of actual cumulative dose received and actual duration of exposure.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to approximately 42 months', 'description': 'ORR is defined as the proportion of patients with a BOR of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 42 months', 'description': 'DOR is the time between the first documented response (CR or PR) and the date of progression according to RECIST v1.1 guidelines, or death due to any cause.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to approximately 42 months', 'description': 'DCR is defined as the proportion of patients with a BOR of CR, PR or stable disease according to RECIST v1.1 guidelines.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to approximately 42 months', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression according to RECIST v1.1 guidelines or death due to any cause.'}, {'measure': 'Area Under the Curve (AUC) of [177Lu]Lu-NNS309', 'timeFrame': 'Cycle 1 Day 1 (Pre-infusion, end of infusion, Post dose (30 minutes (min), 1 hours (hr), 2hr, 4hr, 6hr, 12hr)), Cycle 1 Day 2 (24hr), Cycle 1 Day 3 (48hr), Cycle 1 Day 4 (72hr), Cycle 1 Day 8 (168hr). The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'The \\[177Lu\\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. AUC will be determined by non-compartmental methods.'}, {'measure': 'Total body clearance of [177Lu]Lu-NNS309', 'timeFrame': 'Cycle 1 Day 1 (Pre-infusion, end of infusion, Post dose (30 minutes (min), 1 hours (hr), 2hr, 4hr, 6hr, 12hr)), Cycle 1 Day 2 (24hr), Cycle 1 Day 3 (48hr), Cycle 1 Day 4 (72hr), Cycle 1 Day 8 (168hr). The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'The \\[177Lu\\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Total body clearance will be determined by non-compartmental methods.'}, {'measure': 'Observed maximum blood concentration (Cmax) of [177Lu]Lu-NNS309', 'timeFrame': 'Cycle 1 Day 1 (Pre-infusion, end of infusion, Post dose (30 minutes (min), 1 hours (hr), 2hr, 4hr, 6hr, 12hr)), Cycle 1 Day 2 (24hr), Cycle 1 Day 3 (48hr), Cycle 1 Day 4 (72hr), Cycle 1 Day 8 (168hr). The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'The \\[177Lu\\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Cmax will be determined by non-compartmental methods.'}, {'measure': 'Observed maximum radioactivity concentration (Rmax) of [177Lu]Lu-NNS309', 'timeFrame': 'Cycle 1 Day 1 (Pre-infusion, end of infusion, Post dose (30 minutes (min), 1 hours (hr), 2hr, 4hr, 6hr, 12hr)), Cycle 1 Day 2 (24hr), Cycle 1 Day 3 (48hr), Cycle 1 Day 4 (72hr), Cycle 1 Day 8 (168hr). The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'The \\[177Lu\\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Rmax will be determined by non-compartmental methods.'}, {'measure': 'Volume of distribution (Vz) of [177Lu]Lu-NNS309 during the terminal phase', 'timeFrame': 'Cycle 1 Day 1 (Pre-infusion, end of infusion, Post dose (30 minutes (min), 1 hours (hr), 2hr, 4hr, 6hr, 12hr)), Cycle 1 Day 2 (24hr), Cycle 1 Day 3 (48hr), Cycle 1 Day 4 (72hr), Cycle 1 Day 8 (168hr). The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'The \\[177Lu\\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Vz will be determined by non-compartmental methods.'}, {'measure': 'Terminal elimination half-life (T1/2) of [177Lu]Lu-NNS309', 'timeFrame': 'Cycle 1 Day 1 (Pre-infusion, end of infusion, Post dose (30 minutes (min), 1 hours (hr), 2hr, 4hr, 6hr, 12hr)), Cycle 1 Day 2 (24hr), Cycle 1 Day 3 (48hr), Cycle 1 Day 4 (72hr), Cycle 1 Day 8 (168hr). The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'The \\[177Lu\\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. T1/2 will be determined by non-compartmental methods.'}, {'measure': 'Urinary excretion of radioactivity expressed as a percentage of injected dose (%ID)', 'timeFrame': 'Cycle 1: Pre-infusion, beginning of infusion to first SPECT/CT image acquisition, first SPECT/CT image acquisition to 6 hr post end of infusion (EOI), 6-24hr post EOI, 24-48hr post EOI, 48-72hr post EOI. The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'Urine elimination data for \\[177Lu\\]Lu-NNS309 will be assessed based on decay-corrected urine radioactivity concentration data. Urine elimination data will be expressed as percentage of injected dose (%ID).'}, {'measure': 'Renal clearance of [177Lu]Lu-NNS309', 'timeFrame': 'Cycle 1: Pre-infusion, beginning of infusion to first SPECT/CT image acquisition, first SPECT/CT image acquisition to 6 hr post end of infusion (EOI), 6-24hr post EOI, 24-48hr post EOI, 48-72hr post EOI. The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'Urine samples will be collected over specified time intervals and analyzed for radioactivity. Renal clearance of 177Lu-NNS309 will be summarized using descriptive statistics.'}, {'measure': 'Absorbed dose of [177Lu]Lu-NNS309', 'timeFrame': 'Cycle 1 Day 1, Cycle 1 Day 2 (24hr), Cycle 1 Day 3 (48hr), Cycle 1 Day 4 (72hr), Cycle 1 Day 8 (168hr). The duration of a cycle is 4 weeks or 6 weeks.', 'description': 'Time activity curves (TACs) for the various organs and tumor lesions will be produced as fraction of injected activity per gram of tissue (%ID/g) as a function of time.'}, {'measure': 'Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-NNS309', 'timeFrame': 'From Imaging visit until 3 days after 68Ga-NNS309 administration, assessed up to approximately 3 days.', 'description': 'The distribution of adverse events will be done via the analysis of frequencies for TEAEs and TESAEs and through the monitoring of relevant clinical and laboratory safety parameters.'}, {'measure': 'Visual and quantitative assessment of [68Ga]Ga-NNS309 uptake in normal tissues and tumor lesions over time', 'timeFrame': 'From 0 up to approximately 3 hrs after [68Ga]Ga-NNS309 dosing', 'description': 'After \\[68Ga\\]Ga-NNS309 administration, \\[68Ga\\]Ga-NNS309 PET/CT or PET/MRI will be performed. Standardized uptake values (SUVs) of \\[68Ga\\]Ga-NNS309 in normal tissues and tumor lesions over time will be summarized.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatic ductal adenocarcinoma', 'non-small cell lung cancer', 'breast cancer', 'colorectal cancer', 'radioligand therapy (RLT)', '[177Lu]Lu-NNS309', '[68Ga]Ga-NNS309'], 'conditions': ['Pancreatic Ductal Adenocarcinoma', 'Non-small Cell Lung Cancer', 'HR+/HER2- Ductal and Lobular Breast Cancer', 'Triple Negative Breast Cancer', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[177Lu\\]Lu-NNS309 and the safety and imaging properties of \\[68Ga\\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).', 'detailedDescription': 'The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a \\[68Ga\\]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for \\[177Lu\\]Lu-NNS309 treatment. In the escalation part, different doses of \\[177Lu\\]Lu-NNS309 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of \\[177Lu\\]Lu-NNS309 at the RD(s) determined during the escalation part. The end of study will occur when all patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with one of the following indications:\n* Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy\n* Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy\n* (Dose escalation part only) Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy\n* Patients must have lesions showing 68Ga-NNS309 uptake\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\< 1.5 x 109/L, hemoglobin \\< 9 g/dL, or platelet count \\< 100 x 109/L\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* Creatinine clearance \\< 60 mL/min\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Radiation therapy within 4 weeks prior to the first dose of \\[177Lu\\]Lu-NNS309\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT06562192', 'briefTitle': 'Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers', 'orgStudyIdInfo': {'id': 'CFXX489A12101'}, 'secondaryIdInfos': [{'id': '2023-510356-23', 'type': 'OTHER', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Patients will receive \\[68Ga\\]Ga-NNS309, and if eligible, \\[177Lu\\]Lu-NNS309', 'interventionNames': ['Drug: [68Ga]Ga-NNS309', 'Drug: [177Lu]Lu-NNS309']}], 'interventions': [{'name': '[68Ga]Ga-NNS309', 'type': 'DRUG', 'description': 'Radioligand imaging agent', 'armGroupLabels': ['Arm 1']}, {'name': '[177Lu]Lu-NNS309', 'type': 'DRUG', 'description': 'Radioligand therapy', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela Lool', 'role': 'CONTACT', 'email': 'alool@mednet.ucla.edu'}, {'name': 'Jonathan W Goldman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California LA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Isabel Leonio', 'role': 'CONTACT', 'email': 'ileonio@stanford.edu'}, {'name': 'Farshad Moradi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alberta Lalljie', 'role': 'CONTACT', 'email': 'Lalljie.Albertha@mayo.edu', 'phone': '904-953-7648'}, {'name': 'Ephraim Parent', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin Talluto', 'role': 'CONTACT', 'email': 'jtalluto@mgb.org'}, {'name': 'Shadi Abdar Esfahani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'researchclinicalteam@bamfhealth.com'}, {'name': 'Brandon Mancini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BAMF Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Orange', 'role': 'CONTACT', 'email': 'lisa.orange@bamfhealth.com'}, {'name': 'Brandon Mancini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BAMF Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lucas Hamann', 'role': 'CONTACT', 'email': 'hamann.lucas@mayo.edu', 'phone': '507-538-2155'}, {'name': 'Andrea Wahner Hendrickson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Denisse Harkins', 'role': 'CONTACT', 'email': 'dvelazquez1@mdanderson.org', 'phone': '713-792-2921'}, {'name': 'Jordi Rodon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uni Of TX MD Anderson Cancer Cntr', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather White', 'role': 'CONTACT', 'email': 'hwhite@fredhutch.org'}, {'name': 'Amir Iravani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '1000', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '69677', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '94800', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '45147', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '6423906', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '42123', 'city': 'Reggio Emilia', 'state': 'RE', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '6500HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3584 CX', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28009', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '1211', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1011', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '1-888-669-6682'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+41613241111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}