Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 1:21 PM
Study NCT ID:
NCT04871334
Status:
UNKNOWN
Last Update Posted:
2021-07-23
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicity (DLT)', 'timeFrame': 'From the first dose of study drug up to 4 weeks'}, {'measure': 'Incidence of adverse events and serious adverse event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)) and irAE.', 'timeFrame': 'From enrollment until 90 days after the last dose'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) by RECIST Version 1.1', 'timeFrame': 'From first dose to disease progression or end of study, an average of 2 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From first dose to disease progression, an average of 2 years'}, {'measure': 'Disease control rate (DCR).', 'timeFrame': 'From first dose to disease progression or end of study, an average of 2 years'}, {'measure': 'Progression free survival (PFS).', 'timeFrame': 'From first dose to disease progression or end of study, an average of 2 years'}, {'measure': 'Maximum measured plasma concentration (Cmax) of TWP-101.', 'timeFrame': 'From first dose until 90 days after the last dose'}, {'measure': 'Time to maximum plasma concentration (Tmax) of TWP-101.', 'timeFrame': 'From first dose until 90 days after the last dose'}, {'measure': 'Half-life (T1/2) of TWP-101.', 'timeFrame': 'From first dose until 90 days after the last dose'}, {'measure': 'Immunogenicity profile of TWP-101.', 'timeFrame': 'From first dose until 90 days after the last dose', 'description': 'Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies by meso scale discovery(MSD).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Melanoma', 'Advanced Urothelial Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments\n* ECOG score 0 or 1;\n* Part B: At least 1 measurable lesion according to RECIST 1.1\n\nExclusion Criteria:\n\n* Known hypersensitivity to any ingredient of TWP-101;\n* Receiving any anti-cancer drugs;\n* History of serious systemic diseases;\n* History of serious autoimmune diseases;\n* Pregnancy or lactating women."}, 'identificationModule': {'nctId': 'NCT04871334', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong TheraWisdom Biopharma Co., Ltd.'}, 'officialTitle': 'A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'TWP-101-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Cohort', 'description': 'Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.', 'interventionNames': ['Drug: TWP-101']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Cohort', 'description': 'Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.', 'interventionNames': ['Drug: TWP-101']}], 'interventions': [{'name': 'TWP-101', 'type': 'DRUG', 'otherNames': ['Sytalizumab Injection'], 'description': 'IV infusion Q2W for 4 weeks (28-day cycles)', 'armGroupLabels': ['Dose Escalation Cohort', 'Dose Expansion Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Guo', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '010-88121122'}], 'facility': 'Peking University Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shengbin Ren', 'role': 'CONTACT', 'email': 'shengbin.ren@therawisdom.com', 'phone': '8021-60167707'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong TheraWisdom Biopharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}