Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT05614258
Status:
RECRUITING
Last Update Posted:
2024-08-14
First Post:
2022-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-11-09', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants experiencing dose-limiting toxicities escalating dose levels', 'timeFrame': 'At the end of Cycle 1 (each cycle is 21 days)'}, {'measure': 'Number of participants with adverse events (AE)', 'timeFrame': 'At the end of 90 days post last dose (each cycle is 21 days)'}, {'measure': 'Maximum administered dose (MAD) of ADG206', 'timeFrame': 'At the end of the last dose (each cycle is 21 days)'}, {'measure': 'Maximum tolerated dose (MTD) of ADG 206', 'timeFrame': 'At the end of the last dose (each cycle is 21 days)'}, {'measure': 'Recommended Phase 2 dose (RP2D) of ADG206', 'timeFrame': 'At the end of the last dose (each cycle is 21 days)'}], 'secondaryOutcomes': [{'measure': 'The area under the curve (AUC) of plasma concentration of drug', 'timeFrame': 'At the end of the last dose (each cycle is 21 days)'}, {'measure': 'Immunogenicity endpoints include antidrug antibodies (ADAs)', 'timeFrame': 'At the end of the last dose (each cycle is 21 days)'}, {'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'At the end of the last dose (each cycle is 21 days)'}, {'measure': 'Time to maximum plasma concentration (Tmax)', 'timeFrame': 'At the end of the last dose (each cycle is 21 days)'}, {'measure': 'Lowest plasma concentration (C[trough])', 'timeFrame': 'At the end of the last dose (each cycle is 21 days)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced/Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': 'ADG206 is an activatable prodrug form of a fully human monoclonal antibody (mAb) of the immunoglobulin G1 (IgG1) subclass that specifically targets cluster of differentiation 137 (CD137) (also known as 4-1BB) as a co-stimulatory receptor agonist for the treatment of advanced malignancies.', 'detailedDescription': 'This is a FIH, Phase 1, open-label, multicenter, sequential dose escalation study to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ADG206 in subjects with advanced/metastatic malignancies.\n\nPrimary Objective of the study: To assess safety and tolerability at increasing dose levels of ADG206 in subjects with advanced/metastatic solid tumors who have exhausted their treatment alternatives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists.\n* At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).\n* Adequate organ function.\n* Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.\n* Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.\n\nExclusion Criteria:\n\n* Subjects within washout period of other anti-tumor therapies. .\n* History of prior malignancy other than the cancer under treatment in the study.\n* Major trauma or major surgery within 4 weeks before the first dose of study drug.\n* Serious nonhealing wound, ulcer, or bone fracture.\n* History of significant immune-mediated AE.\n* Central nervous system (CNS) disease involvement.\n* Any evidence of underlying severe liver dysfunction.\n* Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.\n* Clinically significant cardiac disease with insufficient cardiac function.\n* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.\n* Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).\n* Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV) (unless the disease is clinically controlled) .\n* History or risk of autoimmune disease.\n* Subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis. Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis.\n* Any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent.\n* Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG206.\n* Pregnant, lactating, or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05614258', 'briefTitle': 'Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adagene Inc'}, 'officialTitle': 'A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'ADG206-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADG206 dose escalation', 'interventionNames': ['Drug: ADG206']}], 'interventions': [{'name': 'ADG206', 'type': 'DRUG', 'description': 'All participants in this study will receive the study drug ADG206 in one of the designed dosage level. ADG206 will be administered by intravenous infusion over 60-90 minutes on Day 1 of each treatment cycle until disease progression, intolerable toxicities or withdrawal of consent, or up to 2 years.', 'armGroupLabels': ['ADG206 dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5037', 'city': 'Kurralta Park', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Carolyn Bampton', 'role': 'CONTACT'}], 'facility': 'Ashford Cancer Centre Research', 'geoPoint': {'lat': -34.95142, 'lon': 138.56702}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sophia Frentzas', 'role': 'CONTACT'}], 'facility': 'Monash Health', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}], 'centralContacts': [{'name': 'Xiaohong She', 'role': 'CONTACT', 'email': 'Kristine_she@adagene.com', 'phone': '4088389296'}, {'name': 'Jiping Zha', 'role': 'CONTACT', 'email': 'jiping_zha@adagene.com', 'phone': '(650)785-9347'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adagene Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}