Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 3:52 AM
Study NCT ID:
NCT07453394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QLS5132 Combination Therapy in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'C531550', 'term': 'olaparib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 626}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events', 'timeFrame': 'up to 2 years', 'description': 'Incidence and severity of adverse events'}, {'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'From basline to Day 28', '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLDN6 ADC'], 'conditions': ['Gastric Cancer (GC)', 'Non-small Cell Lung Cancer (NSCLC)', 'Endometrial Cancer', 'Advanced Solid Tumors', 'Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion.\n\nThe main questions it aims to answer are:\n\n* In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion?\n* In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types?\n\nParticipants will:\n\n* Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents.\n* Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Advanced solid tumors;\n2. Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1);\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n4. Adequate organ function;\n5. Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral.\n\nExclusion Criteria:\n\n1. Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates \\[ADCs\\]), or any drug containing topoisomerase I inhibitors (including ADCs);\n2. 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;\n3. Progressive or symptomatic brain metastases;\n4. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;\n5. History of significant cardiac disease, or poorly controlled diabetes mellitus;\n6. History of recurrent autoimmune diseases;\n7. History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);\n8. History of a second primary malignancy;\n9. If female, is pregnant or breastfeeding;\n10. Be allergic to any component of QLS5132 or its excipients.'}, 'identificationModule': {'nctId': 'NCT07453394', 'briefTitle': 'QLS5132 Combination Therapy in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'QLS5132-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLS5132 combined wtih bevacizumab', 'description': 'QLS5132 in combination with bevacizumab', 'interventionNames': ['Drug: QLS5132; Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'QLS5132 combined wtih platinum', 'description': 'QLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab', 'interventionNames': ['Drug: QLS5132; Platinum; Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'QLS5132 combined wtih Olaparib', 'description': 'QLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab', 'interventionNames': ['Drug: QLS5132; Olaparib; Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'QLS5132 combined wtih immune checkpoint inhibitors', 'description': 'QLS5132 in combination with immune checkpoint inhibitors', 'interventionNames': ['Drug: QLS5132; QL1706; QL2107']}, {'type': 'EXPERIMENTAL', 'label': 'QLS5132 combined with immune checkpoint inhibitors and chemotherapy', 'description': 'QLS5132 in combination with immune checkpoint inhibitors and chemotherapy', 'interventionNames': ['Drug: QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin']}], 'interventions': [{'name': 'QLS5132; Bevacizumab', 'type': 'DRUG', 'description': 'Intravenous infusion，Q3W', 'armGroupLabels': ['QLS5132 combined wtih bevacizumab']}, {'name': 'QLS5132; Platinum; Bevacizumab', 'type': 'DRUG', 'description': 'Intravenous infusion，Q3W', 'armGroupLabels': ['QLS5132 combined wtih platinum']}, {'name': 'QLS5132; Olaparib; Bevacizumab', 'type': 'DRUG', 'description': 'Olaparib is oral; all others are intravenous infusion，Q3W', 'armGroupLabels': ['QLS5132 combined wtih Olaparib']}, {'name': 'QLS5132; QL1706; QL2107', 'type': 'DRUG', 'description': 'Intravenous infusion，Q3W', 'armGroupLabels': ['QLS5132 combined wtih immune checkpoint inhibitors']}, {'name': 'QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin', 'type': 'DRUG', 'description': 'Intravenous infusion，Q3W', 'armGroupLabels': ['QLS5132 combined with immune checkpoint inhibitors and chemotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tao Zhu, PhD', 'role': 'CONTACT', 'email': 'zhutao@zjcc.org.cn', 'phone': '+86 13858065156'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}