Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 11:13 AM
Study NCT ID:
NCT06942767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': 'up to 42 days following first dose', 'description': 'Dose Limiting Toxicity，for Dose Escalation Stage'}, {'measure': 'MTD', 'timeFrame': 'up to 42 days following first dose', 'description': 'Maximum Tolerated Dose，for Dose Escalation Stage.'}, {'measure': 'ORR (Objective Response Rate)', 'timeFrame': 'Approximately 24 months', 'description': 'ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator per RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'AE (adverse events)', 'timeFrame': 'Approximately 24 months', 'description': 'AEs are any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of anti-drug antibody (ADA) Positive Participants', 'timeFrame': 'Approximately 24 months', 'description': 'Immunogenicity will be measured by the number of participants that are ADA positive.'}, {'measure': 'DOR (Duration of Response)', 'timeFrame': 'Approximately 24 months', 'description': 'DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first)'}, {'measure': 'PFS (Progression Free Survival)', 'timeFrame': 'Approximately 24 months', 'description': "PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of radiological progressive disease or death due to any cause (whichever occurs first)."}, {'measure': 'OS (Overall Survival)', 'timeFrame': 'Approximately 24 months', 'description': 'OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.'}, {'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'Approximately 24 months', 'description': 'Cmax will be derived from the PK serum samples collected.'}, {'measure': 'Terminal elimination half-life (T1/2)', 'timeFrame': 'Approximately 24 months', 'description': 'T1/2 will be derived from the PK serum samples collected.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CLDN18.2, gastric or gastroesophageal junction (GEJ) adenocarcinoma'], 'conditions': ['Gastric Adenocarcinoma', 'Gastroesophageal Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.', 'detailedDescription': 'QLS31905 is a bispecific antibody targeting CD3 and CLDN18.2 independently developed by Qilu Pharmaceutical Co., Ltd.\n\nQL2107 is a biosimilar of pembrolizumab (Keytruda®) developed by Qilu Pharmaceutical Co., Ltd.\n\nThis is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histopathological or cytological examination;\n* Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;\n* No prior systemic anti-tumor treatment for locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.\n\nExclusion Criteria:\n\n* Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;\n* Subjects had other second primary malignancies within 5 years prior to the first dose;\n* Subjects with clinically significant hemorrhage within 3 months before the first dose'}, 'identificationModule': {'nctId': 'NCT06942767', 'briefTitle': 'Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'An Open-label, Multicenter Phase II Clinical Study of QLS31905 for Injection Combined With QL2107 Injection and XELOX Regimen in the First-line Treatment of CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma', 'orgStudyIdInfo': {'id': 'QLS31905-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLS31905+QL2107+ XELOX', 'description': 'QLS31905+QL2107+ oxaliplatin + capecitabine', 'interventionNames': ['Drug: QLS31905 for Injection', 'Drug: QL2107 Injection', 'Drug: Oxaliplatin Injection', 'Drug: Capecitabine Tablets']}], 'interventions': [{'name': 'QLS31905 for Injection', 'type': 'DRUG', 'description': 'QLS31905 for Injection', 'armGroupLabels': ['QLS31905+QL2107+ XELOX']}, {'name': 'QL2107 Injection', 'type': 'DRUG', 'description': 'QL2107 Injection', 'armGroupLabels': ['QLS31905+QL2107+ XELOX']}, {'name': 'Oxaliplatin Injection', 'type': 'DRUG', 'description': 'Oxaliplatin Injection', 'armGroupLabels': ['QLS31905+QL2107+ XELOX']}, {'name': 'Capecitabine Tablets', 'type': 'DRUG', 'description': 'Capecitabine Tablets', 'armGroupLabels': ['QLS31905+QL2107+ XELOX']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lin Shen, PHD', 'role': 'CONTACT', 'email': 'linshenpku@163.com', 'phone': '010-881965671'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}