Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-04 @ 4:31 AM
Study NCT ID:
NCT03478995
Status:
COMPLETED
Last Update Posted:
2020-05-11
First Post:
2018-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712767', 'term': 'efineptakin alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': 'up to 24 months', 'description': 'Incidence of nature of DLTs'}, {'measure': 'AE', 'timeFrame': 'up to 24 months', 'description': 'Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.0'}, {'measure': 'ECG test evaluated by QTc', 'timeFrame': 'up to 24 months', 'description': 'Change QTc from baseline (\\> 500 msec)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) profile', 'timeFrame': 'up to cycle 3 day 1(approximately 9 weeks)', 'description': 'Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)'}, {'measure': 'Anti-tumor activity', 'timeFrame': 'up to 24 months', 'description': 'Objective response, defined as a complete response (CR) or partial response (PR) per RECIST v.1.1, as determined by the investigator'}, {'measure': 'Immunogenicity', 'timeFrame': 'up to 24 months', 'description': 'Incidence of anti-drug antibodies (ADAs) during the study'}, {'measure': 'Exploratory Biomarker', 'timeFrame': 'up to 24 months', 'description': 'Changes in immune infiltrates, immune-related gene expression in tumor tissue prior to and during study treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase1b'], 'conditions': ['Locally Advanced or Metastatic Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '40490502', 'type': 'DERIVED', 'citation': 'Kim GM, Kim S, Lee MA, Byun MS, Choi D, Yang SH, Woo J, Sung YC, Shin EC, Park SH, Kim TW, Sohn J. GX-I7, a long-acting IL-7, safely and effectively increased peripheral CD8+/CD4+ T cells and TILs in patients with locally advanced or metastatic solid tumours. Br J Cancer. 2025 Sep;133(4):524-532. doi: 10.1038/s41416-025-03069-3. Epub 2025 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'Patients will be enrolled in two stages:\n\n* Dose-escalation stage: Approximately 15-30 patients will be enrolled.\n* Dose-expansion stage: 6-12 patients will be enrolled. Dose-escalation slots will be filled first, then dose-expansion slots.', 'detailedDescription': '* Dose-escalation stage : designed as classical 3+3 to determine MTD or RP2D to evaluate approximately GX-I7.\n* Dose-expansion stage : designed to enroll additional 6-12 patients to acquire additional safety and pharmacodynamic data to more fully inform the dose selection for RP2D'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed Informed Consent Form (ICF)\n* Age ≥ 19 years\n* Able to comply with the study protocol, in the investigator's judgment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy ≥ 12 weeks\n* Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1)\n* Serum pregnancy test for women of childbearing potential (including women who have had a tubal ligation) must be performed and documented as negative within 14 days prior to Cycle 1, Day 1\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n* Patients with histologic documentation of locally advanced, recurrent, or metastatic incurable solid tumors that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate\n* Patients with measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n* Inability to comply with study and follow-up procedures\n* Pregnancy, lactation, or breastfeeding\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse\n* Poorly controlled Type 2 diabetes mellitus defined as a screening hemoglobin A1C ≥ 8% or a fasting plasma glucose ≥ 160 mg/dL (or 8.8 mmol/L)\n* Major surgical procedure within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the study\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy\n* History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n* Primary CNS malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins"}, 'identificationModule': {'nctId': 'NCT03478995', 'briefTitle': 'Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genexine, Inc.'}, 'officialTitle': 'A Phase 1b, Open Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'GX-I7-CA-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GX-I7', 'description': 'Determined dose of GX-I7 on Day1 of each cycle', 'interventionNames': ['Drug: GX-I7']}], 'interventions': [{'name': 'GX-I7', 'type': 'DRUG', 'description': 'GX-I7 25mg/ml/vial', 'armGroupLabels': ['GX-I7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital, of the Catholic University", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joo Hyuk Sohn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University Health System, Severance Hospital'}, {'name': 'Tae Won Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Oncology, Asan Medical Center'}, {'name': 'Myoung-Ah Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Medical Oncology, Seoul St. Mary's Hospital, of the Catholic University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genexine, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}