Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT06351020
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2024-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C553458', 'term': 'apatinib'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'experimental arm:LM-302 control arm:Apatinib or Irinotecan'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 375}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-07', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'up to 42 months', 'description': 'OS was defined defined as the time from date of randomization until death from any cause.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'up to 42 months', 'description': 'PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'From start of treatment to date of documented disease progression, up to approximately 42 months', 'description': 'defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months', 'description': 'defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'From start of treatment to date of documented disease progression, up to approximately 42 months', 'description': 'defined as the proportion of participants who achieved CR, PR, or stable disease (SD) for a minimum of 6 weeks during study treatment, based on Investigator assessment.'}, {'measure': 'AE and SAE', 'timeFrame': 'From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose', 'description': 'Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0'}, {'measure': 'Evaluate the immunogenicity of LM-302', 'timeFrame': 'up to 42 months', 'description': 'Anti-drug antibody (ADA) will be detected, the titer of ADA will be evaluated using the validated assay.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of LM-302', 'timeFrame': 'up to 42 months', 'description': 'Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of LM-302', 'timeFrame': 'up to 42 months', 'description': 'Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of LM-302', 'timeFrame': 'up to 42 months', 'description': 'Trough concentration will be evaluated using PopPK model and simulation.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of total antibody', 'timeFrame': 'up to 42 months', 'description': 'Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of total antibody', 'timeFrame': 'up to 42 months', 'description': 'Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of total antibody', 'timeFrame': 'up to 42 months', 'description': 'Trough concentration will be evaluated using PopPK model and simulation.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of MMAE', 'timeFrame': 'up to 42 months', 'description': 'Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of MMAE', 'timeFrame': 'up to 42 months', 'description': 'Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.'}, {'measure': 'Evaluation of pharmacokinetic characteristics of MMAE', 'timeFrame': 'up to 42 months', 'description': 'Trough concentration will be evaluated using PopPK model and simulation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced or Metastatic GC and GCJ Adenocarcinoma']}, 'descriptionModule': {'briefSummary': "This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years old, male and female\n* Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).\n* Has received and progressed on at least 2 lines of systemic therapy. A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy.\n* Centrally confirmed CLDN18.2-positive\n* HER2 negative\n* At least one measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1)\n* ECOG: 0-1\n* Expected survival ≥12 weeks;\n* Good blood reserve and liver, kidney and coagulation function\n* Willing to provide informed consent for study participation.\n\nExclusion Criteria:\n\n* Within the first 5 years of randomization, there is a history of malignant tumors other than GC/GEJ adenocarcinoma, except for skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, and skin squamous cell carcinoma that have been cured and cured after treatment\n* Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation\n* Urine protein qualitative result ≥ 3+, or urine protein qualitative result is 2+and 24-hour urine protein quantification\\>1g\n* Individuals with a history of severe cardiovascular and cerebrovascular diseases\n* Individuals who are unable to control or have serious illnesses, including but not limited to active infections requiring systemic antibiotic treatment within 2 weeks prior to initial medication, interstitial pneumonia/lung disease requiring intervention during screening, and tumor related pain requiring local treatment during screening\n* Current peripheral sensory or motor neuropathy ≥ grade 2\n* Uncontrollable third space effusion in clinical practice\n* Received or planned to undergo major surgery or intervention during the study period within the first 28 days of randomization\n* The researcher determined that there are other situations that are not suitable for participation in this study'}, 'identificationModule': {'nctId': 'NCT06351020', 'briefTitle': 'LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'LaNova Medicines Limited'}, 'officialTitle': "A Phase III, Open-Label, Multi Center, Randomized Study of LM-302 Versus Treatment of Physician's Choice (TPC) in Patients With CLDN18.2-Positive, Locally Advanced or Metastatic Gastric(GC) and Gastroesophageal Junction(GEJ) Adenocarcinoma.", 'orgStudyIdInfo': {'id': 'LM302-03-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LM-302', 'description': 'Patients will accept LM-302 monotherapy', 'interventionNames': ['Drug: LM-302']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Physician's choice Apatinib or Irinotecan", 'description': 'Patients will accept Apatinib or Irinotecan monotherapy'}], 'interventions': [{'name': 'LM-302', 'type': 'DRUG', 'description': 'LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle', 'armGroupLabels': ['LM-302']}, {'name': 'Apatinib', 'type': 'DRUG', 'description': 'The subjects will receive Apatinib orally,qd'}, {'name': 'Irinotecan', 'type': 'DRUG', 'description': 'The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'chunmei bai, doctor', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jin li, doctor', 'role': 'CONTACT'}], 'facility': 'Shanghai East Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wei Wang', 'role': 'CONTACT', 'email': 'Weiwang@lanovamed.com', 'phone': '021-68889618'}, {'name': 'Liang Kong', 'role': 'CONTACT', 'email': 'Paulkong@lanovamed.com', 'phone': '021-68889618'}], 'overallOfficials': [{'name': 'Chunmei Bai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}, {'name': 'Jin Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai East Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LaNova Medicines Zhejiang Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}