Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT06188702
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2023-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 308}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2024-01-02', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicities (DLTs)', 'timeFrame': 'Through cycle 1 (each cycle is 28 days)', 'description': 'Phase 1 only'}, {'measure': 'Total number of adverse events (AEs)', 'timeFrame': 'Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years', 'description': 'Phase 1 only'}, {'measure': 'Total number of serious adverse events (SAEs)', 'timeFrame': 'Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years', 'description': 'Phase 1 only'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Through the end of the study (approximately 5 years)', 'description': "Phase 2 only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment and by blinded independent central review (BICR)"}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-vs-time curve (AUC) from 0 to time of last measurable concentration (AUC0-t)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'AUC from 0 to infinity (AUC0-∞)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'AUC over 1 dosing interval at steady state (AUCtau,ss)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'Time to maximum concentration (Tmax)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'Trough concentration (Ctrough)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'Half-life (t½)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'Apparent volume of distribution (Vd/F)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'Apparent clearance (CL/F)', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 and 2'}, {'measure': 'Change from baseline in plasma concentrations of S-adenosylmethionine (SAM) and/or tumor symmetric dimethylarginine (SDMA) residues during treatment', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 1 only'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Through the end of the study (approximately 5 years)', 'description': "Phase 1 only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment"}, {'measure': 'Best overall response (BOR)', 'timeFrame': 'Through the end of the study (approximately 5 years)', 'description': "Phase 1 and 2; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment for Phase 1 and 2, and by BICR only for Phase 2."}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'Through the end of the study (approximately 5 years)', 'description': "Phase 1 and 2; CBR=complete response \\[CR\\]+partial response \\[PR\\]+stable disease \\[SD\\] ) ≥6 months, Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment for Phase 1 and 2, and by BICR only for Phase 2"}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Through the end of the study (approximately 5 years)', 'description': "Phase 1 and 2; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment for Phase 1 and 2, and by BICR only for Phase 2. The time from date of first documented confirmed CR or confirmed PR to date of first documented disease progression or death due to any cause."}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Through the end of the study (approximately 5 years)', 'description': "Phase 1 and 2; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment for Phase 1 and 2, and by BICR only for Phase 2. The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR)."}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Through the end of the study (approximately 5 years)', 'description': 'Phase 2 Only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as assessed by investigator and by BICR'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Through the end of the study (approximately 5 years)', 'description': 'Phase 2 Only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as assessed by investigator and by BICR'}, {'measure': 'Total number of adverse events (AEs)', 'timeFrame': 'Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years', 'description': 'Phase 2 Only'}, {'measure': 'Total number of serious adverse events (SAEs)', 'timeFrame': 'Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years', 'description': 'Phase 2 Only'}, {'measure': 'Number of dose interruptions', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 2 Only'}, {'measure': 'Number of dose reductions', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 2 Only'}, {'measure': 'Dose intensity', 'timeFrame': 'Through the last dose of study treatment (approximately 5 years)', 'description': 'Phase 2 Only'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MAT2A', 'MTAP', 'Solid Tumors', 'PRMT5', 'SAM', 'Synthetic Lethality', 'MTAP deletion', 'MAT2A Inhibitor', 'Advanced Solid Tumors', 'Biliary Tract Cancer', 'Non-small Cell Lung Cancer', 'Pancreatic Adenocarcinoma', 'Gastroesophageal Cancer'], 'conditions': ['MTAP-deleted Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \\[MAT2A\\] inhibitor. TNG462 is a protein arginine N-methyltransferase 5 \\[PRMT5\\] inhibitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Estimated life expectancy ≥3 months.\n* ECOG PS 0-1\n* Participants able to comply with highly effective method of birth control requirements.\n* Participants with histologically confirmed advanced or metastatic solid tumor's (excluding central nervous system tumors other than IDHwt glioblastoma), with measurable disease as per RECIST 1.1 or RANO 2.0 criteria for participants with IDHwt glioblastoma, that have progressed after at least one prior treatment regimen given for advanced/metastatic disease, and for whom additional effective standard therapy is not available.\n* Participants with pre-existing documented MTAP homozygous gene deletion in their tumor tissue, determined using a next generation sequencing in vitro diagnostic test prior to screening.\n* Phase 1 only - Participants (except IDHwt glioblastoma) willing to undergo paired fresh biopsy (pre-treatment and on-treatment) procedure. Exceptions may be made for feasibility and safety concerns. IDHwt glioblastoma must provide archival tissue from most recent surgery or biopsy.\n* Adequate organ functions.\n* Phase 2 only - Participants in dose expansion, except those with IDHwt glioblastoma, must provide newly collected tumor biopsies at screening. If it is not medically feasible, then archival tissue is acceptable if it was collected within 3 months before study entry and no treatment has been received since the most recent biopsy.\n* Phase 2 only - Participants with IDHwt glioblastoma must provide archival tissue from their most recent surgery or biopsy, collected before screening, even if that occurred \\>3 months before study entry.\n* Phase 2 Arm 1a only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after at least 1 prior line of standard-of-care systemic therapy.\n* Phase 2 Arm 1b only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced BTC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after at least 1 prior line of standard-of-care systemic therapy.\n* Phase 2 Arm 1c only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced PDAC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after at least 1 prior line of standard-of-care systemic therapy.\n* Phase 2 Arm 1d only - Participants with any other locally advanced or metastatic malignancies with homozygous deletion of MTAP, who have received and progressed of experienced recurrence during or after receiving at least 1 prior line of standard-of-care systemic therapy.\n* Phase 2 Arm 2a only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced BTC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after receiving at least 1 prior line of standard-of care systemic therapy.\n* Phase 2 Arm 2b only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced gastroesophageal cancer with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after receiving at least 1 prior line of standard-of-care systemic therapy.\n* Phase 2 Arm 2c only - Participants with histologically or cytologically confirmed metastatic or unresectable locally advanced PDAC with homozygous deletion of MTAP, who have progressed or experienced disease recurrence during or after receiving at least 1 prior line of standard-of-care systemic therapy.\n\nExclusion Criteria:\n\n* Inability to take an orally administered drug, or medical disorder or prior surgical resection that may affect the absorption of the study drug.\n* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's Medical monitor and investigator agree and document that it should not be exclusionary.\n* Known prior severe hypersensitivity to any component of the study drug formulation.\n* Major surgery within 4 weeks prior to the first study drug administration or participants who have not recovered from side effects of the surgery.\n* Have a known history of Gilbert's syndrome.\n* Participants with a known clinically significant cardiovascular disease or condition.\n* Participants with thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration.\n* Active brain metastases.\n* Participants who have received systemic anticancer treatment or radiotherapy less than 2 weeks before the first dose of study drug\n* Pregnant or lactating women.\n* Women of childbearing potential who have a positive pregnancy test within 7 days prior to the first day of study drug administration.\n* History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to first study drug intake.\n* Severe or uncontrolled active acute or chronic infection.\n* Participants who have already received a MAT2A or PRMT5 inhibitor.\n* A medical condition that results in increased clinically significant photosensitivity (e.g., solar urticaria, lupus erythematosus, etc.)."}, 'identificationModule': {'nctId': 'NCT06188702', 'briefTitle': 'S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier'}, 'officialTitle': 'A Phase 1/2, Open-label, Multicenter Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Antineoplastic Activity of S095035 (MAT2A Inhibitor) as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP', 'orgStudyIdInfo': {'id': 'CL1-95035-001'}, 'secondaryIdInfos': [{'id': '2025-521249-25-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 Arm 1 - S095035 single-agent dose escalation', 'interventionNames': ['Drug: S095035']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 Arm 2 - S095035-TNG462 combination dose escalation', 'interventionNames': ['Drug: S095035', 'Drug: TNG462']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 1a NSCLC - S095035 single-agent dose expansion', 'description': 'Non-Small Cell Lung Cancer', 'interventionNames': ['Drug: S095035']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 1b BTC - S095035 single-agent dose expansion', 'description': 'Biliary Tract Cancer', 'interventionNames': ['Drug: S095035']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 1c PDAC - S095035 single-agent dose expansion', 'description': 'Pancreatic Ductal Adenocarcinoma', 'interventionNames': ['Drug: S095035']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 1d Basket arm - S095035 single-agent dose expansion', 'interventionNames': ['Drug: S095035']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion', 'description': 'Biliary Tract Cancer', 'interventionNames': ['Drug: S095035', 'Drug: TNG462']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion', 'interventionNames': ['Drug: S095035', 'Drug: TNG462']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion', 'description': 'Pancreatic Ductal Adenocarcinoma', 'interventionNames': ['Drug: S095035', 'Drug: TNG462']}], 'interventions': [{'name': 'S095035', 'type': 'DRUG', 'description': 'S095035 will be taken orally every day in 28-day cycles.', 'armGroupLabels': ['Phase 1 Arm 1 - S095035 single-agent dose escalation', 'Phase 1 Arm 2 - S095035-TNG462 combination dose escalation', 'Phase 2 Arm 1a NSCLC - S095035 single-agent dose expansion', 'Phase 2 Arm 1b BTC - S095035 single-agent dose expansion', 'Phase 2 Arm 1c PDAC - S095035 single-agent dose expansion', 'Phase 2 Arm 1d Basket arm - S095035 single-agent dose expansion', 'Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion', 'Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion', 'Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion']}, {'name': 'TNG462', 'type': 'DRUG', 'description': 'TNG462 will be taken orally every day in 28-day cycles.', 'armGroupLabels': ['Phase 1 Arm 2 - S095035-TNG462 combination dose escalation', 'Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansion', 'Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansion', 'Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of California, San Francisco (Ucsf) School of Medicine', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32746', 'city': 'Lake Mary', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Lake Mary Cancer Center - Florida Cancer Specialists & Research Institute', 'geoPoint': {'lat': 28.75888, 'lon': -81.31784}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Community Health Network', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Dana Farber Cancer Institue', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Taylor Cancer Research Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Scientia Clinical Research', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '3004', 'city': 'Prahran', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'The Alfred', 'geoPoint': {'lat': -37.85114, 'lon': 144.99318}}, {'zip': '4812', 'city': 'Douglas', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Townsville University Hospital', 'geoPoint': {'lat': -19.32394, 'lon': 146.75234}}, {'zip': '7000', 'city': 'Hobart', 'status': 'SUSPENDED', 'country': 'Australia', 'facility': 'Royal Hobart Hospital', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '2100', 'city': 'Copenhagen', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'facility': 'University Hospital Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'facility': 'Odense Universitets Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Georges-François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '13353', 'city': 'Berlin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Charite Universitatsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '40225', 'city': 'Düsseldorf', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Med Fakultaet Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '89081', 'city': 'Ulm', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '20141', 'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'facility': 'Istituto Europeo Di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'facility': 'A.O.U. Seconda Università Degli Studi Di Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'facility': 'Ist. Nazionale Tumori Irccs Fondazione G Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '20098', 'city': 'Rozzano', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'facility': 'Instituto Clinico Humanitas Irccs', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '37134', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Policlinico G.B. Rossi A.O.U.I. Di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '4648681', 'city': 'Aichi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Aichi Cancer Center', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '7910280', 'city': 'Ehime', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Shikoku Cancer Center'}, {'zip': '1358550', 'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'The Cancer Institute Hospital of JFCR', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '8023', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'facility': 'Next Oncology-Hospital Quironsalud Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8035', 'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'facility': "Hospital Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Start Madrid Group - Hm Ciocc', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department', 'role': 'CONTACT', 'email': 'scientificinformation@servier.com', 'phone': '+33 1 55 72 60 00'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicaltrials.servier.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After Marketing Authorization in EEA or US if the study is used for the approval.', 'ipdSharing': 'YES', 'description': 'Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.\n\nAccess can be requested for all interventional clinical studies:\n\n* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).\n* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.\n\nIn addition, access can be requested for all interventional clinical studies in patients:\n\n* sponsored by Servier\n* with a first patient enrolled as of 1 January 2004 onwards\n* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.', 'accessCriteria': 'Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Servier Bio-Innovation LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institut de Recherches Internationales Servier', 'class': 'OTHER'}, {'name': 'Tango Therapeutics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}