Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-29 @ 2:52 AM
Study NCT ID:
NCT05278832
Status:
UNKNOWN
Last Update Posted:
2022-03-14
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of QLS31905 in Patients With Advanced 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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicities(DLTs)', 'timeFrame': '2 years', 'description': 'Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905'}, {'measure': 'Maximum tolerated Dose(MTD)', 'timeFrame': '2 years', 'description': 'To evaluate the safety and tolerability of QLS31905'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': '2 years', 'description': 'Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '2 years', 'description': 'Objective Response Rate (ORR) is the percentage of CR+PR'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '2 years', 'description': 'Disease control Rate (DCR) is the percentage of CR+PR+SD'}, {'measure': 'adverse events (AE)', 'timeFrame': '2 years', 'description': 'To evaluate the safety and tolerability of QLS31905'}, {'measure': 'Cmax', 'timeFrame': '2 years', 'description': 'Maximum concentration (Cmax) of the drug after administration'}, {'measure': 'AUC', 'timeFrame': '2 years', 'description': 'The area under the curve (AUC) of serum concentration of the drug after the administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent.\n2. ≥18 years.\n3. Female or male.\n4. ECOG performance status score 0 or 1.\n5. Histologically or cytologically confirmed diagnosis of advanced solid tumors.\n6. Adequate haematological, hepatic and renal function.\n\nExclusion Criteria:\n\n1. Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment.\n2. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.\n3. Patients with a history of monoclonal antibody allergic reaction.\n4. Known human immunodeficiency virus infection or known symptomatic hepatitis.'}, 'identificationModule': {'nctId': 'NCT05278832', 'briefTitle': 'A Study of QLS31905 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of QLS31905 in Patients With Claudin18.2-positive Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'QLS31905-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLS31905', 'description': 'QLS31905 injection', 'interventionNames': ['Drug: QLS31905']}], 'interventions': [{'name': 'QLS31905', 'type': 'DRUG', 'description': 'QLS31905 injection', 'armGroupLabels': ['QLS31905']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Shen', 'role': 'CONTACT', 'email': 'linshenpku@163.com', 'phone': '010-881965671'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}