protocolSection identificationModule nctId: NCT06322693, orgStudyIdInfo id: 213348, secondaryIdInfos id: 2023-507564-39, type: EUDRACT_NUMBER, briefTitle: A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER), statusModule overallStatus: RECRUITING, startDateStruct date: 2016-07-08, primaryCompletionDateStruct date: 2025-08-29, completionDateStruct date: 2027-02-19, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy., conditionsModule conditions: Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a multi-center, open-label, first-in-human Phase 1 study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 475, type: ESTIMATED, armsInterventionsModule interventions name: TSR-022, interventions name: Nivolumab, interventions name: TSR-042, interventions name: TSR-033, interventions name: Docetaxel, interventions name: Pemetrexed, interventions name: Cisplatin, interventions name: Carboplatin, outcomesModule primaryOutcomes measure: Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs), primaryOutcomes measure: Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs), primaryOutcomes measure: Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs), primaryOutcomes measure: Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs), primaryOutcomes measure: Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications, primaryOutcomes measure: Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, secondaryOutcomes measure: Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1, secondaryOutcomes measure: Part 2 (A, B, C, D) : ORR by Immune related RECIST (irRECIST), secondaryOutcomes measure: Part 2: Duration of response (DOR) by RECIST v 1.1, secondaryOutcomes measure: Part 2 (A, B, C, D) : DOR by irRECIST, secondaryOutcomes measure: Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1, secondaryOutcomes measure: Part 2 (A, B, C, D) : DCR by irRECIST, secondaryOutcomes measure: Part 2: Progression-free survival (PFS) by RECIST v 1.1, secondaryOutcomes measure: Part 2 (A, B, C, D) : PFS by irRECIST, secondaryOutcomes measure: Parts 1 and 2 (A, B, C, D, E, F) : Serum concentration of TSR-022, secondaryOutcomes measure: Part 1d: Serum concentration of TSR-033, secondaryOutcomes measure: Part 1 (c, d, e, f, g ,h): Serum concentration of TSR-042, secondaryOutcomes measure: Part 2 (A, B, C, D, F): Serum concentration of TSR-042, secondaryOutcomes measure: Part 2: Overall survival (OS), secondaryOutcomes measure: Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: Cmin of TSR-022 in combination with nivolumab, secondaryOutcomes measure: Part 1c: Cmin of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab, secondaryOutcomes measure: Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab, secondaryOutcomes measure: Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: t1/2 of TSR-022 and in combination with nivolumab, secondaryOutcomes measure: Part 1c: t1/2 of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: AUCtau of TSR-022 and in combination with nivolumab, secondaryOutcomes measure: Part 1c: AUCtau of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022, secondaryOutcomes measure: Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022, secondaryOutcomes measure: Part 1 (c, d, e, f, g ,h): Number of participants with ADA to TSR-042, secondaryOutcomes measure: Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042, secondaryOutcomes measure: Part 1d: Number of participants with ADA to TSR-033, secondaryOutcomes measure: Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to death, secondaryOutcomes measure: Part 2F: Percent change from Baseline in Alpha-fetoprotein (AFP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, status: COMPLETED, city: Goodyear, state: Arizona, zip: 85338, country: United States, geoPoint lat: 33.43532, lon: -112.35821, locations facility: GSK Investigational Site, status: COMPLETED, city: Scottsdale, state: Arizona, zip: 85258, country: United States, geoPoint lat: 33.50921, lon: -111.89903, locations facility: GSK Investigational Site, status: COMPLETED, city: Tucson, state: Arizona, zip: 85704, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: GSK Investigational Site, status: COMPLETED, city: Tucson, state: Arizona, zip: 85711, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: GSK Investigational Site, status: RECRUITING, city: Encinitas, state: California, zip: 92024, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Edward F McClay, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.03699, lon: -117.29198, locations facility: GSK Investigational Site, status: RECRUITING, city: Fountain Valley, state: California, zip: 92708, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Haresh S. Jhangiani, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.70918, lon: -117.95367, locations facility: GSK Investigational Site, status: RECRUITING, city: Los Angeles, state: California, zip: 90024, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Antoni Ribas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: GSK Investigational Site, status: RECRUITING, city: Los Angeles, state: California, zip: 90025, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Peter D Boasberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: GSK Investigational Site, status: RECRUITING, city: San Marcos, state: California, zip: 92069, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Edward F McClay, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.14337, lon: -117.16614, locations facility: GSK Investigational Site, status: RECRUITING, city: Whittier, state: California, zip: 90606, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Paul La Porte, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.97918, lon: -118.03284, locations facility: GSK Investigational Site, status: RECRUITING, city: Aurora, state: Colorado, zip: 80012, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Allen L. Cohn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: GSK Investigational Site, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Theresa Medina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: GSK Investigational Site, status: COMPLETED, city: Denver, state: Colorado, zip: 80218, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: GSK Investigational Site, status: RECRUITING, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Gerald Falchook, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.73915, lon: -104.9847, locations facility: GSK Investigational Site, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06511, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Patricia M Lorusso, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: GSK Investigational Site, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20007, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michael Pishvaian, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.89511, lon: -77.03637, locations facility: GSK Investigational Site, status: COMPLETED, city: Jacksonville, state: Florida, zip: 32224, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: GSK Investigational Site, status: COMPLETED, city: Miami Beach, state: Florida, zip: 33140, country: United States, geoPoint lat: 25.79065, lon: -80.13005, locations facility: GSK Investigational Site, status: RECRUITING, city: Sarasota, state: Florida, zip: 34232, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Judy S Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.33643, lon: -82.53065, locations facility: GSK Investigational Site, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Zeynep Eroglu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, locations facility: GSK Investigational Site, status: COMPLETED, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: GSK Investigational Site, status: COMPLETED, city: Augusta, state: Georgia, zip: 30912, country: United States, geoPoint lat: 33.47097, lon: -81.97484, locations facility: GSK Investigational Site, status: RECRUITING, city: Arlington Heights, state: Illinois, zip: 60005, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Richard S Siegel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.08836, lon: -87.98063, locations facility: GSK Investigational Site, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jason J Luke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: GSK Investigational Site, status: RECRUITING, city: Niles, state: Illinois, zip: 60714, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Richard S Siegel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.01892, lon: -87.80284, locations facility: GSK Investigational Site, status: RECRUITING, city: Iowa City, state: Iowa, zip: 52242-1009, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mohammed Milhem, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66113, lon: -91.53017, locations facility: GSK Investigational Site, status: COMPLETED, city: Wichita, state: Kansas, zip: 67214, country: United States, geoPoint lat: 37.69224, lon: -97.33754, locations facility: GSK Investigational Site, status: COMPLETED, city: Louisville, state: Kentucky, zip: 40202, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: GSK Investigational Site, status: RECRUITING, city: Pikeville, state: Kentucky, zip: 41501, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Christopher C. Croot, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.47927, lon: -82.51876, locations facility: GSK Investigational Site, status: RECRUITING, city: Rockville, state: Maryland, zip: 20850, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: John M Wallmark, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.084, lon: -77.15276, locations facility: GSK Investigational Site, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Keith Flaherty, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: GSK Investigational Site, status: COMPLETED, city: Detroit, state: Michigan, zip: 48202, country: United States, geoPoint lat: 42.33143, lon: -83.04575, locations facility: GSK Investigational Site, status: COMPLETED, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, locations facility: GSK Investigational Site, status: COMPLETED, city: Hackensack, state: New Jersey, zip: 07601, country: United States, geoPoint lat: 40.88593, lon: -74.04347, locations facility: GSK Investigational Site, status: RECRUITING, city: Bronx, state: New York, zip: 10461, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Sanjay Goel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.84985, lon: -73.86641, locations facility: GSK Investigational Site, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Janice Mehnert, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: GSK Investigational Site, status: COMPLETED, city: Cincinnati, state: Ohio, zip: 45242, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: GSK Investigational Site, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: David Bajor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, locations facility: GSK Investigational Site, status: RECRUITING, city: Toledo, state: Ohio, zip: 43623, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Rex B Mowat, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66394, lon: -83.55521, locations facility: GSK Investigational Site, status: RECRUITING, city: Eugene, state: Oregon, zip: 97401, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Joseph Fiorillo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.05207, lon: -123.08675, locations facility: GSK Investigational Site, status: COMPLETED, city: Portland, state: Oregon, zip: 97213-2982, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: GSK Investigational Site, status: COMPLETED, city: Bethlehem, state: Pennsylvania, zip: 18015, country: United States, geoPoint lat: 40.62593, lon: -75.37046, locations facility: GSK Investigational Site, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15213-2584, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Diwakar Davar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: GSK Investigational Site, status: RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Theodore G Gourdin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, locations facility: GSK Investigational Site, status: COMPLETED, city: Greenville, state: South Carolina, zip: 29605, country: United States, geoPoint lat: 34.85262, lon: -82.39401, locations facility: GSK Investigational Site, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jeffrey Roger Infante, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, locations facility: GSK Investigational Site, status: COMPLETED, city: Austin, state: Texas, zip: 78705, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: GSK Investigational Site, status: RECRUITING, city: Dallas, state: Texas, zip: 75246, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Charles L Cowey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: GSK Investigational Site, status: COMPLETED, city: Fort Worth, state: Texas, zip: 76104, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: GSK Investigational Site, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Julio Peguero, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: GSK Investigational Site, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Timothy Yap, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: GSK Investigational Site, status: RECRUITING, city: Longview, state: Texas, zip: 75601, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Donald Richards, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.5007, lon: -94.74049, locations facility: GSK Investigational Site, status: RECRUITING, city: McAllen, state: Texas, zip: 78503-1298, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Habib M. H. 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