Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 1:39 PM
Study NCT ID:
NCT05274204
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
2023-02-27
First Post:
2022-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Patient Expanded Access to CA102N
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'TEMPORARILY_NOT_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Advanced or Metastatic Colorectal Cancer (mCRC)']}, 'descriptionModule': {'briefSummary': 'This study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.', 'detailedDescription': 'In the individual patient expanded access, the subject who was enrolled in Phase 1 trial (Study Number: HS-CA102N-101) Part 2 (dose expansion) and had completed at least 12 treatment cycles with CA102N combined with trifluridine /tipiracil (LONSURF) will be provided access to treatment with CA102N (0.72 mg/kg Nimesulide Equivalent of CA102N).'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05274204', 'briefTitle': 'Individual Patient Expanded Access to CA102N', 'organization': {'class': 'INDUSTRY', 'fullName': 'Holy Stone Healthcare Co., Ltd'}, 'officialTitle': 'Expanded Access to CA102N in One Patient Who Completed at Least 12 Cycles of Combination Therapy of CA102N Plus Lonsurf in Clinical Study Number of HS-CA102N-101', 'orgStudyIdInfo': {'id': 'HS-CA102N-102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CA102N', 'type': 'DRUG', 'otherNames': ['Nim-HA Conjugate']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Holy Stone Healthcare Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}