Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 5:38 AM
Study NCT ID:
NCT06932094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Clinical Study of QLS5132 Monotherapy in 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': 256}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events and serious adverse events', 'timeFrame': 'up to 2 years', 'description': 'Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0'}, {'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': '28days', 'description': 'Highest administered dose with \\< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants'}, {'measure': 'Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'up to 2 years', 'description': 'Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data'}], 'secondaryOutcomes': [{'measure': 'Maximum Serum Concentration of QLS5132 (Cmax)', 'timeFrame': '21 days', 'description': 'PK assessment'}, {'measure': 'Maximum Serum Concentration of QLS5132 at Steady State (Cmax,ss)', 'timeFrame': '63 days', 'description': 'PK assessment'}, {'measure': 'Minimum Serum Concentration of QLS5132 at Steady State (Cmin,ss)', 'timeFrame': '63 days', 'description': 'PK assessment'}, {'measure': 'Time of Maximum Serum Concentration of QLS5132 (Tmax)', 'timeFrame': '21 days', 'description': 'PK assessment'}, {'measure': 'Terminal Half-life (T1/2) of Serum QLS5132', 'timeFrame': '63 days', 'description': 'PK assessment'}, {'measure': 'Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5132', 'timeFrame': '21 days', 'description': 'PK assessment'}, {'measure': 'Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5132', 'timeFrame': '63 days', 'description': 'PK assessment'}, {'measure': 'Volume of Distribution (Vd) of QLS5132', 'timeFrame': '63 days', 'description': 'PK assessment'}, {'measure': 'Clearance (CL) of QLS5132', 'timeFrame': '63 days', 'description': 'PK assessment'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 2 years', 'description': 'Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 2 years', 'description': 'Time from CR or PR to objective disease progression or death to any cause'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': '1 years', 'description': 'Time from start of treatment to disease progression'}, {'measure': '1 Year Overall Survival (1YOS)', 'timeFrame': 'up to 2 years', 'description': 'Proportion of participants alive at 1 year from the start of treatment to death from any cause'}, {'measure': '2 Year Overall Survival (2YOS)', 'timeFrame': '2 years', 'description': 'Proportion of participants alive at 2 years from the start of treatment to death from any cause'}, {'measure': 'Number of anti-drug antibody (ADA) Positive Participants', 'timeFrame': 'up to 2 years', 'description': 'Immunogenicity will be measured by the number of participants that are ADA positive'}, {'measure': 'Number of neutralizing antibody (Nab) Positive Participants', 'timeFrame': 'up to 2 years', 'description': 'Immunogenicity will be measured by the number of participants that are Nab positive'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': "The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion):\n\n* Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels.\n* Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1\\~3 selected dose levels follow successful Phase 1a results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced solid tumors;\n* Measurable disease, per RECIST v1.1;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* Adequate organ function;\n* Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral;\n\nExclusion Criteria:\n\n* Previous treatment with drugs targeting CLDN6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);\n* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;\n* Progressive or symptomatic brain metastases;\n* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;\n* History of significant cardiac disease, or poorly controlled diabetes mellitus;\n* History of recurrent autoimmune diseases;\n* History of myelodysplastic syndrome (MDS) or AML;\n* History of other active malignant tumors within 3 years before signing the informed consent form;\n* If female, is pregnant or breastfeeding;\n* Be allergic to any component of QLS5132 or its excipients.'}, 'identificationModule': {'nctId': 'NCT06932094', 'briefTitle': 'Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'QLS5132-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Finding and Expansion- QLS5132 Monotherapy', 'description': 'Intravenous infusion，Q3W', 'interventionNames': ['Drug: QLS5132']}], 'interventions': [{'name': 'QLS5132', 'type': 'DRUG', 'description': 'antibody drug conjugate (ADC).', 'armGroupLabels': ['Dose Finding and Expansion- QLS5132 Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'contacts': [{'name': 'Tao Zhu', 'role': 'CONTACT'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Tao Zhu, PhD', 'role': 'CONTACT', 'email': 'zhutao@zjcc.org.cn', 'phone': '13858065156'}, {'name': 'Zhengbo Song, PhD', 'role': 'CONTACT', 'email': 'songzb@zjcc.org.cn', 'phone': '13857153345'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}