Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT06081920
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2023-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of IBI363 in Subjects With Advanced Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], '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': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2023-10-07', 'studyFirstSubmitQcDate': '2023-10-07', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AE（Adverse event）', 'timeFrame': '2 years'}, {'measure': 'ORR（Objective response rate）', 'timeFrame': '2 years'}, {'measure': 'DoR（duration of response）', 'timeFrame': '2 years'}, {'measure': 'PFS (progression free survival)', 'timeFrame': '2 years'}, {'measure': 'DCR (disease control rate)', 'timeFrame': '2 years'}, {'measure': 'TTR (time to response)', 'timeFrame': '2 years'}, {'measure': 'TTP (time to progression)', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'OS（overall survival）', 'timeFrame': '2 years'}, {'measure': 'PK concentration: IBI363 serum concentration', 'timeFrame': '2 years'}, {'measure': 'ADA (Anti-drug antibody)', 'timeFrame': '2 years'}, {'measure': 'Nab (Neutralizing antibody)', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th edition staging III-IV). Progression or recurrence after at least first-line systemic standard treatment.\n2. At least one measurable lesion (target lesion) per RECIST v1.1.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Life expectancy of 3 months or more.\n5. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.\n\nExclusion Criteria:\n\n1. Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug.\n2. Active or symptomatic central nervous system metastasis.\n3. At baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin\\<90 g/L; Absolute neutrophil count (ANC)\\<1.5 × 109/L; Platelet count\\<100 × 109/L.\n4. At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin\\>1.5 × ULN; AST or ALT\\>3 × ULN; If it is tumor liver metastasis, AST or ALT\\>5.0 × ULN; Serum creatinine\\>1.5 × ULN or CCr\\<45 mL/min, using the Cockcroft Fault formula to calculate CCr (using actual body weight); Albumin\\<30 g/L.\n5. At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR\\>1.5 × ULN (\\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin time (aPTT))\\>1.5 × ULN (\\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN).\n6. History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational drug, unless sufficient treatment has been given and the investigator believes that the condition is stable.\n7. Uncontrolled bleeding or known tendency to bleed.'}, 'identificationModule': {'nctId': 'NCT06081920', 'briefTitle': 'A Study of IBI363 in Subjects With Advanced Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma', 'orgStudyIdInfo': {'id': 'CIBI363A201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBI363', 'interventionNames': ['Biological: IBI363']}], 'interventions': [{'name': 'IBI363', 'type': 'BIOLOGICAL', 'description': 'IBI363 monotherapy', 'armGroupLabels': ['IBI363']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Guo', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '13911233048'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Guo', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '13911233048'}], 'facility': 'Peking University Cancer Hospital & Institute, Beijing, China,', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Chen', 'role': 'CONTACT', 'email': 'chenyu1980@fjmu.edu.cn', 'phone': '18950395132'}], 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '450044', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianbin Liang', 'role': 'CONTACT', 'email': 'Wslxb666@126.com', 'phone': '15038212930'}], 'facility': "The Third people's hospital of Zhengzhou", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '410031', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianan Li', 'role': 'CONTACT', 'email': 'lixianan2001@163.com;puxingxiang@hnca.org.cn', 'phone': '18874933879'}, {'name': 'Xingxiang Pu', 'role': 'CONTACT', 'phone': '15874180022'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhengyun Zou', 'role': 'CONTACT', 'email': 'Zouzhengyun001@163.com', 'phone': '13815891858'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330052', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Zhang', 'role': 'CONTACT', 'email': 'zhang_l202@163.com', 'phone': '13672215566'}], 'facility': 'The first affiliated hospital of Nanchang university', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '130012', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueying Zhang', 'role': 'CONTACT', 'email': '554597526@qq.com', 'phone': '13304329877'}], 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Di Wu', 'role': 'CONTACT', 'email': 'wudi888991@163.com', 'phone': '13944888991'}], 'facility': 'The first hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cuihua Yi', 'role': 'CONTACT', 'email': 'yicuihua@sdu.edu.cn', 'phone': '18560082871'}], 'facility': 'Qilu Hospital of Shandong university', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '030032', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huijing Feng', 'role': 'CONTACT', 'email': 'doctorfh@sina.com', 'phone': '15834121235'}], 'facility': 'Shanxi Bethune Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '650118', 'city': 'Kunming', 'state': 'Yunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Li', 'role': 'CONTACT', 'email': 'likelikelike@162.com', 'phone': '13888052830'}], 'facility': 'Yunan Cancer Hospital', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Haiyun Zuo', 'role': 'CONTACT', 'email': 'haiyun.zuo@innoventbio.com', 'phone': '0512-69566088'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}