Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05024305
Status:
UNKNOWN
Last Update Posted:
2022-03-09
First Post:
2021-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 81}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2021-08-22', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events/serious adverse event related with TWP-102 injection', 'timeFrame': 'From enrollment until 90 days after the last dose'}, {'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'From the first dose of study drug up to 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum measured plasma concentration (Cmax) of TWP-102 injection.', 'timeFrame': 'From first dose until 90 days after the last dose'}, {'measure': 'Time to maximum plasma concentration (Tmax) of TWP-102 injection.', 'timeFrame': 'From first dose until 90 days after the last dose'}, {'measure': 'Half-life (T1/2) of TWP-102 injection.', 'timeFrame': 'From first dose until 90 days after the last dose'}, {'measure': 'Immunogenicity profile of TWP-102 injection.', '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.'}, {'measure': 'Objective Response Rate (ORR)', '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 or end of study, 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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments;\n* At least 1 measurable lesion.\n* ECOG score 0 or 1;\n* Life expectancy of ≥ 3 months;\n\nExclusion Criteria:\n\n* Known hypersensitivity to any ingredient of TWP-102;\n* Receiving any anti-cancer drugs within 4 weeks;\n* History of serious systemic diseases;\n* History of serious autoimmune diseases;\n* Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \\> 1 severity that is related to prior anti-cancer therapy. (except alopecia)\n* Pregnancy or lactating women.'}, 'identificationModule': {'nctId': 'NCT05024305', 'briefTitle': 'Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong TheraWisdom Biopharma Co., Ltd.'}, 'officialTitle': 'A Multi-center, Phase I, Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.', 'orgStudyIdInfo': {'id': 'TWP-102-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Cohort', 'description': 'Four dose levels of TWP-102 injection will be tested by BOIN study design.', 'interventionNames': ['Drug: TWP-102 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Cohort', 'description': 'Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors.', 'interventionNames': ['Drug: TWP-102 injection']}], 'interventions': [{'name': 'TWP-102 injection', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['Dose Escalation Cohort', 'Dose Expansion Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingyuan Zhang', 'role': 'CONTACT', 'phone': '0451-86298070'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Shengbin Ren', 'role': 'CONTACT', 'email': 'shengbin.ren@therawisdom.com', 'phone': '8021-60167707'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong TheraWisdom Biopharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}