Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 9:10 AM
Study NCT ID:
NCT06440057
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2024-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label phase I/II study, divided into 2 parts:\n\nPart 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.\n\nPart 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years of age;\n* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* Participants were deemed unsuitable for participating in the study by the investigator for any reason.'}, 'identificationModule': {'nctId': 'NCT06440057', 'briefTitle': 'Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}, 'officialTitle': 'A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.', 'orgStudyIdInfo': {'id': 'ZG006-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': 'A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg.', 'interventionNames': ['Biological: ZG006']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion', 'description': 'Participants will receive the RP2D identified in Dose Escalation Study .', 'interventionNames': ['Biological: ZG006']}], 'interventions': [{'name': 'ZG006', 'type': 'BIOLOGICAL', 'description': 'ZG006 will be administered as an intravenous (IV) infusion.', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianming Xu', 'role': 'CONTACT', 'email': 'jmxu2003@163.com', 'phone': '13910866712'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shangdi Ning', 'role': 'CONTACT', 'email': 'ningsd@zelgen.com', 'phone': '+86-0512-57309965'}], 'overallOfficials': [{'name': 'Jason Wu', 'role': 'STUDY_CHAIR', 'affiliation': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}