Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT05651932
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2022-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C524865', 'term': 'carfilzomib'}, {'id': 'C467566', 'term': 'pomalidomide'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Escalation: Determination of Recommended Phase 2 Dose (RP2D) and/or Maximum Tolerated Dose (MTD)', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'Incidence of dose-limiting toxicity (DLTs), treatment-emergent adverse events (TEAEs), treatment-related AEs, and clinically significant changes in laboratory test results'}], 'secondaryOutcomes': [{'measure': 'Disease Specific Response to KTX-1001± Combination Therapy', 'timeFrame': 'Duration of Study', 'description': 'Objective Response Rate (ORR) Duration of Response (DOR) Progression Free Survival (PFS) Minimal Residual Disease (MRD)\n\nPer IMWG Consensus Criteria for Response and Minimal Residual Disease Assessment in Multiple Myeloma'}, {'measure': 'Pharmacokinetics & Pharmacodynamics KTX-1001± Combination Therapy', 'timeFrame': 'Duration of Study', 'description': 'Maximum plasma concentration (Cmax) of KTX-1001 Time to achieve Cmax (tmax) for KTX-1001 Area under the plasma concentration-time curve (AUC) for KTX-1001'}, {'measure': 'Safety profile of KTX-1001± Combination Therapy', 'timeFrame': 'Duration of Study', 'description': 'Frequency and severity of TEAEs, treatment-related AEs, and clinically significant changes in laboratory test results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSD2', 'MMSET', 'WHSC1', 'T4;14', 'T(4;14)', 'translocation', 'myeloma', 'RRMM'], 'conditions': ['Multiple Myeloma', 'Myeloma', 'Myeloma Multiple']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.k36tx.com/about-ktx-1001', 'label': 'K36 Therapeutics'}]}, 'descriptionModule': {'briefSummary': 'A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2/WHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM).', 'detailedDescription': 'This is a Phase I, open-label, dose-escalation and expansion study in adult patients with RRMM.\n\nIn the dose escalation phase (Part A), patients will be evaluated for DLTs during Cycle 1 (28 days). The KTX-1001 MTD, RP2D, and schedule will be determined.\n\nIn the dose expansion phase (Part B), patients with t(4;14) will receive KTX-1001 at the RP2D alone and in combination with investigational therapy Mezigdomide or SOC therapy (dexamethasone, carfilzomib or pomalidomide) to further define safety and tolerability and provide preliminary efficacy information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria for Dose-Expansion:\n\n* ≥ 18 years of age\n* ECOG score ≤ 1\n* Multiple myeloma (as per IMWG)\n\n * ≥ 3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody\n * Patients must be refractory to their last prior therapy\n * Cohorts A1/A2: Patients must have exhausted available therapeutic options that are expected to provide a meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance, or refusal of the therapy\n * t(4;14) confirmed by standard of care FISH testing\n* Measurable disease, including at least 1 of the following criteria:\n\n * Serum M protein ≥ 0.50 g/dL (by SPEP)\n * Serum IgA ≥ 0.50 g/dL (IgA myeloma patients)\n * Urine M protein ≥ 200 mg/24 h (by UPEP)\n * sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio)\n * Bone marrow plasma cells ≥ 30% (if only criterion for measurability)\n* Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only)\n\nKey Exclusion Criteria for Dose-Expansion:\n\n* Treatment with the following therapies in the specified time period prior to first dose:\n\n * Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2\n * Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D\n * Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks\n * Cellular therapies ≤ 8 weeks\n * Autologous transplant \\< 100 days\n * Allogenic transplant ≤ 6 months, or \\> 6 months with active GVHD\n * Major surgery ≤ 4 weeks\n* Current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis\n* MM with extramedullary disease (applies to Cohorts A1 \\& A2: KTX-1001, C1 \\& C2: Carfilzomib, and D: Pomalidomide only)\n* Active CNS disease\n* Inadequate bone marrow function\n* Inadequate renal, hepatic, pulmonary, and cardiac function\n* Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol.\n* Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 14 days or 5 half-lives prior to first dose\n* Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)\n* Active malignancy not related to myeloma requiring therapy within \\< 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.'}, 'identificationModule': {'nctId': 'NCT05651932', 'briefTitle': 'A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'K36 Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1 Study of KTX-1001, an Oral, First-In-Class, Selective, and Potent MMSET Catalytic Inhibitor That Suppresses H3K36me2 in Patients With Relapsed and Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'KTX-MMSET-001'}, 'secondaryIdInfos': [{'id': 'EUCTR No: 2022-500801-41-00', 'type': 'OTHER', 'domain': 'European Medicines Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A (Single agent): KTX-1001 + dexamethasone', 'description': 'Cohort A1 (single agent): KTX-1001 at RP2D1 + dex Cohort A2 (single agent): KTX-1001 at RP2D2 + dex', 'interventionNames': ['Drug: Cohort A1 & A2: KTX-1001']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B (Mezigdomide): KTX-1001 + Mezigdomide + dex', 'description': 'Cohort B1 (Mezigdomide): KTX-1001 at RP2D1 + Mezigdomide + dex Cohort B2 (Mezigdomide):: KTX-1001 at RP2D2 + Mezigdomide + dex', 'interventionNames': ['Drug: Cohort B1 & B2: KTX-1001+Mezigdomide']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C (carfilzomib/KYPROLIS®): KTX-1001 + carfilzomib + dex', 'description': 'Cohort C1 (carfilzomib/KYPROLIS®): KTX-1001 at RP2D1 + carfilzomib + dex Cohort C2 (carfilzomib/KYPROLIS®): KTX-1001 at RP2D2 + carfilzomib + dex', 'interventionNames': ['Drug: Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D (pomalidomide): KTX-1001 + pomalidomide + dex', 'description': 'Cohort D (pomalidomide): KTX-1001 at RP2D1 or RP2D2 + pomalidomide + dex', 'interventionNames': ['Drug: Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid)']}], 'interventions': [{'name': 'Cohort A1 & A2: KTX-1001', 'type': 'DRUG', 'otherNames': ['KTX-1001', 'Dexamethasone'], 'description': 'KTX-1001: Orally for 28 days each cycle until progression. Dexamethasone: Orally once weekly', 'armGroupLabels': ['Cohort A (Single agent): KTX-1001 + dexamethasone']}, {'name': 'Cohort B1 & B2: KTX-1001+Mezigdomide', 'type': 'DRUG', 'otherNames': ['Mezigdomide'], 'description': 'Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once weekly Drug: Mezigdomide Dexamethasone: Orally once weekly', 'armGroupLabels': ['Cohort B (Mezigdomide): KTX-1001 + Mezigdomide + dex']}, {'name': 'Cohort C1 & C2: KTX-1001 + Carfilzomib (KYPROLIS®)', 'type': 'DRUG', 'otherNames': ['Carfilzomib (KYPROLIS®)', 'Dexamethasone'], 'description': 'Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once weekly Drug: Carfilzomib (KYPROLIS®): IV, once weekly for 3 weeks in each 28-day cycle', 'armGroupLabels': ['Cohort C (carfilzomib/KYPROLIS®): KTX-1001 + carfilzomib + dex']}, {'name': 'Cohort D: KTX-1001+ pomalidomide (Pomalyst, Imnovid)', 'type': 'DRUG', 'otherNames': ['Pomalidomide (Pomalyst, Imnovid)', 'Dexamethasone'], 'description': 'Drug: KTX-1001: Orally for 28 days each cycle until progression Drug: Dexamethasone: Orally once a week Drug: Pomalidomide (Pomalyst, Imnovid): Orally, for 21 days in each 28-day cycle', 'armGroupLabels': ['Cohort D (pomalidomide): KTX-1001 + pomalidomide + dex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alfred Chung, MD', 'role': 'CONTACT', 'email': 'alfred.chung@ucsf.edu', 'phone': '415-353-8467'}, {'name': 'Phu Lam', 'role': 'CONTACT', 'email': 'phu.lam@ucsf.edu', 'phone': '415-858-7994'}, {'name': 'Alfred Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSF Medical Center - Hematology and Blood and Marrow Transplant Clinic', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vivek Roy, MD', 'role': 'CONTACT', 'email': 'roy.vivek@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Ahsan Rasheed', 'role': 'CONTACT', 'email': 'rasheed.ahsan@mayo.edu', 'phone': '904-953-2000'}, {'name': 'Vivek Roy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Hospital - Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sagar Lonial, MD, FACP', 'role': 'CONTACT', 'email': 'sloni01@emory.edu', 'phone': '404-778-1900'}, {'name': 'Megan Marshall', 'role': 'CONTACT', 'email': 'megan.marshall@emory.edu', 'phone': '404-778-5204'}, {'name': 'Sagar Lonial, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Yee, MD', 'role': 'CONTACT', 'email': 'ayee1@mgh.harvard.edu', 'phone': '614-724-4000'}, {'name': 'Alicia Marggraf', 'role': 'CONTACT', 'email': 'amarggraf@mgh.harvard.edu', 'phone': '617-724-7319'}, {'name': 'Andrew Yee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Dingli, MD, PhD', 'role': 'CONTACT', 'email': 'dingli.david@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Thomas Nelson', 'role': 'CONTACT', 'email': 'nelson.thomas2@mayo.edu', 'phone': '855-776-0015'}, {'name': 'David Dingli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic - Transplant Center - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David S Siegel, MD, PhD', 'role': 'CONTACT', 'email': 'davids.siegel@hmhn.org', 'phone': '551-996-8704'}, {'name': 'Palka Anand', 'role': 'CONTACT', 'email': 'Palka.Anand@hmhn.org', 'phone': '551-996-3040'}, {'name': 'David S Siegel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Saad Usmani, MD', 'role': 'CONTACT', 'email': 'usmanis@mskcc.org', 'phone': '646-608-4165'}, {'name': 'Laura Guttentag', 'role': 'CONTACT', 'email': 'guttenl@mskcc.org', 'phone': '646-415-4804'}, {'name': 'Saad Usmani, MD, MBA, FACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cindy Varga, MD', 'role': 'CONTACT', 'email': 'Cindy.Varga@atriumhealth.org', 'phone': '980-442-2000'}, {'name': 'Kelly Bumgarnert', 'role': 'CONTACT', 'email': 'Kelly.bumgarner@atriumhealth.org'}, {'name': 'Cindy Varga, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health, Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cristina Gasparetto, MD', 'role': 'CONTACT', 'email': 'gaspa001@mc.duke.edu', 'phone': '919-668-8222'}, {'name': 'Quinna Lawson', 'role': 'CONTACT', 'email': 'quinna.marshburn@duke.edu', 'phone': '919-668-2556'}, {'name': 'Cristina Gasparetto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ed Stadtmauer, MD', 'role': 'CONTACT', 'email': 'Edward.Stadtmauer@pennmedicine.upenn.edu', 'phone': '215-316-5151'}, {'name': 'Sara Whittington', 'role': 'CONTACT', 'email': 'sara.whittington@pennmedicine.upenn.edu'}, {'name': 'Ed Stadtmauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jesus Berdeja, MD', 'role': 'CONTACT', 'email': 'jberdeja@tnonc.com', 'phone': '615-320-5090'}, {'name': 'Austin Windsor', 'role': 'CONTACT', 'email': 'awindsor@tnonc.com', 'phone': '(629) 278-3554'}, {'name': 'Jesus Berdeja, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aimaz Afrough, MD', 'role': 'CONTACT', 'email': 'aimaz.afrough@utsouthwestern.edu', 'phone': '214-645-4673'}, {'name': 'Yu (Joyce) Wang', 'role': 'CONTACT', 'email': 'Yu.wang@utsouthwestern.edu', 'phone': '(214) 645-9859'}, {'name': 'Aimaz Afrough, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Suzanne Trudel, MSc, MD', 'role': 'CONTACT', 'email': 'suzanne.trudel@uhn.ca', 'phone': '416-946-4566'}, {'name': 'Saima Dean', 'role': 'CONTACT', 'email': 'saima.dean@uhnresearch.ca', 'phone': '416-946-4501', 'phoneExt': 'X5241'}, {'name': 'Suzanne Trudel, MSc, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Health Network (UHN) - Princess Margaret Cancer Centre (Princess Margaret Hospital)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cyrille Touzeau, MD', 'role': 'CONTACT', 'email': 'cyrille.touzeau@chu-nantes.fr', 'phone': '+332 40-08-40-29'}, {'name': 'Laetitia Mallard', 'role': 'CONTACT', 'email': 'laetitia.mallard@chu-nantes.fr', 'phone': '+332 40-08-32-14'}, {'name': 'Cyrille Touzeau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Leleu, MD', 'role': 'CONTACT', 'email': 'Xavier.LELEU@chu-poitiers.fr'}, {'name': 'Romane Giraud', 'role': 'CONTACT', 'email': 'Romane.GIRAUD@chu-poitiers.fr', 'phone': '33516604306'}, {'name': 'Xavier Leleu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Poitiers (CHU de Poitiers)', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Bories, MD', 'role': 'CONTACT', 'email': 'bories.pierre@iuct-oncopole.fr', 'phone': '+335 31-15-65-14'}, {'name': 'Alicia Perez', 'role': 'CONTACT', 'email': 'perez.alicia@iuct-oncopole.fr'}, {'name': 'Pierre Bories, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Universitaire du Cancer de Toulouse - Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': "Villeneuve-d'Ascq", 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Salomon Manier, MD', 'role': 'CONTACT', 'email': 'Salomon.manier@chru-lille.fr', 'phone': '03 59 50 75 69'}, {'name': 'Salomon Manier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitaire de Lille', 'geoPoint': {'lat': 50.61669, 'lon': 3.16664}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Paula Rodriguez, MD, PhD', 'role': 'CONTACT', 'email': 'paurodriguez@unav.es', 'phone': '+34 94825-5400', 'phoneExt': '5813'}, {'name': 'Raquel Antón Saiz', 'role': 'CONTACT', 'email': 'eecc@unav.es', 'phone': '34 948 255 400', 'phoneExt': 'Ext 2754'}, {'name': 'Paula Rodriguez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clínica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Laura Rosinol, MD', 'role': 'CONTACT', 'email': 'lrosinol@clinic.cat', 'phone': '+34-932-279-219'}, {'name': 'Julio Vidal', 'role': 'CONTACT', 'email': 'contratoshemato@recerca.clinic.cat', 'phone': '34 932275484'}, {'name': 'Laura Rosinol, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital ClÃ-nic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joaquín Martínez López, MD', 'role': 'CONTACT', 'email': 'jmarti01@med.ucm.es', 'phone': '34 917792877'}, {'name': 'Joaquín Martínez López, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria-Victoria Mateos Manteca, MD, PhD', 'role': 'CONTACT', 'email': 'mvmateos@usal.es', 'phone': '+34 92329-1100', 'phoneExt': '56933'}, {'name': 'Carmen Arias', 'role': 'CONTACT', 'email': 'ensayosclinicos@ibsal.es', 'phone': '34 923210960'}, {'name': 'Maria-Victoria Mateos Manteca, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto de Investigacion Biomedica de Salamanca (IBSAL)', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}], 'centralContacts': [{'name': 'Soo Bang, MHSA', 'role': 'CONTACT', 'email': 'sbang@k36tx.com', 'phone': '1-347-342-7199'}, {'name': 'Miriam Barnett, Ph.D.', 'role': 'CONTACT', 'email': 'mbarnett@k36tx.com', 'phone': '1-716-523-2141'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'K36 Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}