Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT06026605
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2023-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients with Advanced Malignant Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anti-drug antibodies (ADA)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The proportion of anti-drug antibodies (ADA) after WTX212A infusion'}, {'measure': 'The absolute value of immune cell subsets', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The absolute value of immune cell subsets'}, {'measure': 'The percentage of immune cell subsets', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The percentage of immune cell subsets'}, {'measure': 'The proportion of PD-L1 expression in tumor cells/immune cells', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The proportion of PD-L1 expression in tumor cells/immune cells'}], 'primaryOutcomes': [{'measure': 'incidence of adverse events', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The incidence of Adverse Events during the treatment of WTX212A injection'}, {'measure': 'incidence of treatment related adverse events (TRAE)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The incidence of TRAE during the treatment of WTX212A injection'}, {'measure': 'incidence of severe adverse events (SAE)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The incidence of SAE during the treatment of WTX212A injection'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'through study completion, an average of 1 months', 'description': 'Cmax'}, {'measure': 'Tmax', 'timeFrame': 'through study completion, an average of 1 months', 'description': 'Tmax'}, {'measure': 'AUC0-t', 'timeFrame': 'through study completion, an average of 1 months', 'description': 'AUC0-t'}, {'measure': 't1/2', 'timeFrame': 'through study completion, an average of 1 months', 'description': 't1/2'}, {'measure': 'CL', 'timeFrame': 'through study completion, an average of 1 months', 'description': 'CL'}, {'measure': 'Cmin,ss', 'timeFrame': 'through study completion, an average of 1 months', 'description': 'Cmin,ss'}, {'measure': 'Cmax,ss', 'timeFrame': 'through study completion, an average of 1 months', 'description': 'Cmax,ss'}, {'measure': 'Tmax,ss', 'timeFrame': 'through study completion, an average of 1 months', 'description': 'Tmax,ss'}, {'measure': 'AUC（0-τ）ss.', 'timeFrame': 'through study completion, an average of 1 months', 'description': 'AUC（0-τ）ss.'}, {'measure': 'the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after WTX212A infusion'}, {'measure': 'Objecive Response Rate (ORR)', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'According to Response Evaluation Criteria In Solid Tumors Version 1.1'}, {'measure': 'Anti-drug antibody (ADA)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'escribe the number and percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unresectable or Metastatic Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This trial is a multi-center, open-label investigator-initiated clinical study (IIT) to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.\n\nThe study was divided into two phases: dose escalation and dose expansion', 'detailedDescription': 'The study was divided into two phases: dose escalation and dose expansion Detailed Description: This trial is a multi-center, open-label investigator-initiated clinical study(llT)to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Must signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures; 2. Aged 18 to 75 years old (including threshold); 3. Histopathology diagnosed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment; 4. ECOG≤1； 5. Expected life ≥ 3 months； 6. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; 7. Women of childbearing age must have a negative pregnancy testing results within ≤ 7 days before the first trial drug administration.\n\nExclusion Criteria:\n\n\\- 1. Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases, 2. Pleural and ascitic fluids with clinical symptoms and the need for repeated drainage; 3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia; 4. History of adverse events related to the use of IO drugs that require permanent cessation of IO treatment; 5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.\n\n6\\. Symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment; 7. Hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; 8. Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;'}, 'identificationModule': {'nctId': 'NCT06026605', 'briefTitle': 'A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients with Advanced Malignant Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'A MulticenterOpen LableDose Escalat Tion and Dose Expansion Clinical Study to Evaluate the Safety, Tolerance and Ini Itial Effectiveness of WTX212A Injection in Patients with Unresectable or Metasta Atic Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'Reboot-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WTX212A', 'description': 'WTX212A infusion once every 21 days', 'interventionNames': ['Drug: WTX212A']}], 'interventions': [{'name': 'WTX212A', 'type': 'DRUG', 'description': 'WTX212A infusion once every 21 days', 'armGroupLabels': ['WTX212A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Zhang', 'role': 'CONTACT', 'phone': '13858108798'}], 'facility': 'the First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Qi Zhang, M.D.', 'role': 'CONTACT', 'email': 'qi.zhang@zju.edu.cn', 'phone': '13858108798'}, {'name': 'Qihan Fu, M.D.', 'role': 'CONTACT', 'email': 'ayfuqihan@126.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'TingBo Liang', 'investigatorAffiliation': 'Zhejiang University'}}}}