Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-29 @ 6:33 AM
Study NCT ID:
NCT05086692
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Beta-only IL-2 ImmunoTherapY Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'C536928', 'term': 'Turcot syndrome'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential dose escalation (MDNA11 monotherapy and MDNA11 + pembrolizumab) followed by dose expansion with MDNA11 monotherapy and combination (MDNA11 + pembrolizumab).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Analysis of immune characteristics of the tumor microenvironment', 'timeFrame': 'Up to 24 months', 'description': 'Measured by change in Tumor Infiltrating Lymphocyte (TIL) levels'}], 'primaryOutcomes': [{'measure': 'MDNA11 Recommended Dose for Expansion for monotherapy (mRDE) and Recommended Dose for Expansion for combination (cRDE)', 'timeFrame': '24 months', 'description': 'Evaluation of tolerability as measured by number of patients with dose limiting toxicities (DLTs)'}, {'measure': 'Incidence of Treatment Related Adverse Events (TRAEs)', 'timeFrame': '24 months', 'description': 'Rate of TRAEs in patients with advanced solid tumors'}, {'measure': 'Incidence of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': '24 months', 'description': 'Rate of TEAEs in patients with advanced solid tumors'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic characteristics on MDNA11 - Cmax (ug/mL)', 'timeFrame': 'Up to 24 months', 'description': 'Maximum observed serum drug concentration'}, {'measure': 'Pharmacokinetic characteristics on MDNA11 - Tmax (h)', 'timeFrame': 'Up to 24 months', 'description': 'Time to maximum observed serum drug concentration'}, {'measure': 'Pharmacokinetic characteristics on MDNA11 - AUClast (h.ug/mL)', 'timeFrame': 'Up to 24 months', 'description': 'Area under the serum concentration vs time curve from time zero to the last measurable concentration'}, {'measure': 'Immunogenicity of MDNA11 (anti-drug antibodies)', 'timeFrame': 'Up to 24 months', 'description': 'Incidence and persistence of anti-drug antibodies to MDNA11'}, {'measure': 'Pharmacodynamic effects of MDNA11', 'timeFrame': 'Up to 24 months', 'description': 'Measurement of translational parameters - Flow cytometry analysis of immune cells in blood and serum measurements of cytokine levels'}, {'measure': 'Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Overall Response Rate (ORR)', 'timeFrame': 'Approximately 24 months', 'description': 'Assessed by RECIST v1.1 and iRECIST; CR+PR/Evaluable N'}, {'measure': 'Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Disease Control Rate (DCR)', 'timeFrame': 'Approximately 24 months', 'description': 'CR+PR+SD/Evaluable N'}, {'measure': 'Anti-tumor activity of MDNA11 (alone or in combination with CPI) - Progression Free Survival (PFS)', 'timeFrame': 'Approximately 24 months', 'description': 'Time from signing ICF to disease progression'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IL-2', 'IL2', 'Interleukin-2', 'cancer', 'metastatic', 'ccRCC', 'TNBC', 'NSCLC', 'CRC', 'GEJ', 'intrahepatic', 'extrahepatic', 'MCC', 'SCCHN', 'CSCC', 'Gastroesophageal Junction', 'advanced', 'unresectable', 'MSI-H', 'dMMR', 'Microsatellite Instability-High', 'Mismatch Repair Deficient', 'PD-1', 'immunotherapy', 'anti-PD-1', 'BCC', 'RCC', 'HCC', 'Tumor Mutation Burden High', 'TMB-H', 'PDAC'], 'conditions': ['Advanced Solid Tumor', 'Unresectable Solid Tumor', 'Clear Cell Renal Cell Carcinoma', 'Triple Negative Breast Cancer', 'Non-Small Cell Lung Cancer Squamous', 'Non-Small Cell Lung Cancer Non-squamous', 'Colorectal Cancer (MSI-H)', 'Gastric Cancer', 'Cervical Cancer', 'Basal Cell Carcinoma', 'Bladder Cancer', 'Merkel Cell Carcinoma', 'Squamous Cell Carcinoma of Head and Neck', 'Cutaneous Squamous Cell Carcinoma', 'Pleural Mesothelioma', 'Esophageal Cancer', 'Endometrial Carcinoma', 'Solid Tumor', 'Solid Tumor, Adult', 'MSI-H Solid Malignant Tumor', 'Cancer With A High Tumor Mutational Burden', 'Epithelial Ovarian Carcinoma', 'Primary Peritoneal Cancer', 'Gastroesophageal Junction (GEJ) Cancer', 'Acral Melanoma', 'Mucosal Melanoma', 'Cutaneous Melanoma', 'DMMR Solid Malignant Tumor', 'Fallopian Tube Cancer', 'Ovarian Cancer', 'MSI-H Cancer', 'DMMR Cancer', 'Pancreas Adenocarcinoma (MSI-H)', 'Skin Cancer', 'Viral Cancer', 'Cervical Cancers', 'Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.', 'detailedDescription': 'The study drug, MDNA11, long-acting "beta-only" recombinant interleukin-2 (rIL-2). MDNA11 specifically engineered to overcome the shortcomings of rhIL-2 (aldesleukin) by preferentially activating immune effector cells (CD8+ T- and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2.\n\nThe study will be conducted at up to 30 clinical sites following regulatory authority and institutional review board / independent ethics committee (IRB/ IEC) approval and completion of informed consent. The study will be conducted in multiple parts:\n\n* Monotherapy (MDNA11 alone) dose escalation\n* Monotherapy (MDNA11 alone) dose expansion in select tumor types\n* Combination (MDNA11 + pembrolizumab) dose escalation\n* Combination (MDNA11 + pembrolizumab) dose expansion in select tumor types\n\nApproximately 115 patients will be enrolled.\n\nAfter commencing treatment (first exposure of MDNA11 alone or MDNA11 + pembrolizumab), tumor assessment by CT/MRI will be performed every 8 weeks ± 1 week until immune confirmed progressive disease ("iCPD") by iRECIST, discontinuation of study drug(s), withdrawal of consent or loss to follow-up. Treatment beyond progression may be permitted if criteria are met. Patients can withdraw from participation at any time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male Female (Women of Childbearing Potential will be subject to pregnancy testing)', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\<2 weeks of radiotherapy) to non-CNS disease.\n * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue/solid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator."}, 'identificationModule': {'nctId': 'NCT05086692', 'acronym': 'ABILITY-1', 'briefTitle': 'A Beta-only IL-2 ImmunoTherapY Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicenna Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'MDNA11-01'}, 'secondaryIdInfos': [{'id': 'KEYNOTE-E53', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme, LLC'}, {'id': 'MK3475-E53', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme, LLC'}, {'id': '2023-507536-21-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDNA11', 'description': 'MDNA11 is a long-acting "beta-only" recombinant interleukin-2 (rIL-2) albumin fusion', 'interventionNames': ['Drug: MDNA11', 'Drug: Pembrolizumab (KEYTRUDA®)']}], 'interventions': [{'name': 'MDNA11', 'type': 'DRUG', 'otherNames': ['Interleukin-2 (IL-2)-albumin'], 'description': 'MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg): until determining the monotherapy Recommended Dose for Expansion (mRDE).', 'armGroupLabels': ['MDNA11']}, {'name': 'Pembrolizumab (KEYTRUDA®)', 'type': 'DRUG', 'description': 'MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE).', 'armGroupLabels': ['MDNA11']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Providence Saint John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Boca Raton Regional Hospital', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Emory - Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Scientia Clinical Research', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2109', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Macquarie University', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4556', 'city': 'Buderim', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'University of the Sunshine Coast', 'geoPoint': {'lat': -26.68443, 'lon': 153.05705}}, {'zip': '4120', 'city': 'Greenslopes', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Gallipoli Medical Research Foundation', 'geoPoint': {'lat': -27.50815, 'lon': 153.04951}}, {'zip': 'M4W 3E2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'D07 R2WY', 'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'facility': 'Mater Misericordiae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '1649-035', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'START Lisbon - Centro de Ensaios Clínicos, ULS Sta Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4200-072', 'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Instituto Portugues De Oncologia Do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Seoul', 'state': 'Gangnam-gu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'South Korea', 'facility': 'The Catholic University of Korea St. Vincent Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Seoul', 'state': 'Jongno-gu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08916', 'city': 'Badalona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': "Institut Catala d'Oncologia (ICO)-Badalona", 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08023', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'START Barcelona / HM Nou Delfos', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'START Madrid / Hospital Universitario Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Hm Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '33011', 'city': 'Oviedo', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias (HUCA)', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '28850', 'city': 'Torrejón', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario de Torrejon', 'geoPoint': {'lat': 40.25, 'lon': -1.2}}], 'centralContacts': [{'name': 'Nina Merchant', 'role': 'CONTACT', 'email': 'nmerchant@medicenna.com', 'phone': '604-340-3081'}, {'name': 'Melissa Coello', 'role': 'CONTACT', 'email': 'mcoello@medicenna.com', 'phone': '267-476-2313'}], 'overallOfficials': [{'name': 'Nina Merchant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medicenna Therapeutics'}, {'name': 'Arash Yavari, MBBS', 'role': 'STUDY_CHAIR', 'affiliation': 'Medicenna Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicenna Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}