[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"LaNova Medicines Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":231},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,40,63,86,109,129,150,171,190,210],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100643977","phase-2-a-study-of-lm-168-combined-with-other-anti-tumor-treatments-in-participants-with-advanced-solid-tumors-100643977",false,"NCT07669415","A Study of LM-168 Combined With Other Anti-tumor Treatments in Participants With Advanced Solid Tumors","A Phase II，Open Label,Multicenter Study to Evaluate the Efficacy,Safety,and Tolerability of LM-168 Combined With Other Anti-tumor Therapies in Participants With Advanced Solid Tumor Trials","Inclusion Criteria:\n\n* Participants who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure.\n* Aged ≥18 years old, male or female when sign the Informed consent form (ICF).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.\n* Life expectancy ≥ 3 months.\n* In dose escalation stage, participants must have histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.\n* In dose expansion stage, participants must have histological or cytological confirmation of selected advanced solid tumors.\n* Pre-treatment archived tumour tissue (within 5 years) or on treatment could be provided for biomarker analysis optionally.\n* At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.\n* Participants must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.\n* Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study\n\nExclusion Criteria:\n\n* Received any other investigational product or treatment within 28 days prior to the first dose of LM-168.\n* Received anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) agents, any other immunotherapy or oncology immune-oncology (IO) drugs within 28 days prior to the first dose of LM-168; or permanently discontinued prior immunotherapy due to immune-related adverse events (irAEs). All adverse events (AEs) from previous anti-tumor treatments have not fully resolved or resolved to Grade 1 prior to screening. Requirement for additional immunosuppressants (other than low-dose corticosteroids) to control irAEs.\n* Received other anti-tumor treatments prior to the first dose of LM-168, as specified below:\n\n  1. Received limited-field palliative radiotherapy within 14 days prior to the first dose (excluding radiotherapy solely for pain control of bone metastases).\n  2. Received chemotherapy, small-molecule targeted agents (e.g., tyrosine kinase inhibitors) or hormonal therapies within 14 days prior to the first dose or within 5 half-lives of the respective agent (whichever is longer).\n  3. Received biologic therapy or immunotherapy within 28 days prior to the first dose or within 5 half-lives of the respective agent (whichever is shorter).\n  4. Received traditional Chinese medicines with anti-tumor indications within 14 days prior to the first dose.\n  5. Received nitrosoureas or mitomycin C within 42 days prior to the first dose.\n* AEs from prior anti-tumor treatments have not recovered to Grade ≤ 1 per NCI CTCAE Version 6.0. Exceptions include: toxicities assessed by the Investigator to pose no safety risks (e.g., alopecia), long-term radiation-related toxicities with Grade ≤ 2, and hypothyroidism stabilized with hormonal replacement therapy.\n* Uncontrolled tumor-related pain. Participants requiring analgesic treatment must have been on a stable analgesic dose prior to study entry.\n* Known active brain metastases or leptomeningeal metastases.\n* Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.\n* Esophageal or gastric varices requiring immediate clinical intervention, or a history of variceal bleeding; except for participants with stable conditions confirmed by endoscopic evaluation within 3 months prior to the first study drug administration.\n* History of hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh Class B or higher.\n* Tumor invasion into adjacent vital organs (e.g., aorta, heart, pericardium, superior vena cava, trachea, esophagus, etc.), or at risk of developing esophagotracheal fistula or esophagopleural fistula.\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea).\n* History of Grade ≥ 3 hypersensitivity reactions to monoclonal antibody-based therapies.\n* Experienced Grade ≥ 3 irAEs during prior immunotherapy, or discontinued prior immunotherapy due to severe or life-threatening irAEs.\n* Received systemic corticosteroids (prednisone equivalent \\> 10 mg daily) or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of LM-168. Topical, ophthalmic, intra-articular, intranasal and inhaled corticosteroids are permitted.\n* Known history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis and glomerulonephritis (see Appendix 3 for the complete list of autoimmune diseases). Exception: participants with autoimmune hypothyroidism maintained on a stable dose of thyroid replacement hormones.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonia, interstitial lung disease or severe radiation pneumonitis; or evidence of active pneumonia on chest CT scan during the screening period.\n* Received any live vaccine within 28 days prior to the first dose.\n* Underwent major surgery or interventional procedures within 28 days prior to the first dose of LM-168 (excluding tumor biopsy, puncture and other minor procedures).\n* Severe cardiovascular and cerebrovascular diseases,\n* Uncontrolled or severe concomitant diseases, including ongoing or active infections (e.g., active COVID-19\u002FSARS-CoV-2 infection, syphilis) requiring therapeutic antibiotics and\u002For other medications. SARS-CoV-2 testing is not mandatory for study enrollment but shall comply with local clinical practice guidelines and standards.\n* History of immunodeficiency disorders, including other acquired or congenital immunodeficiencies; or history of solid organ transplantation, allogeneic bone marrow transplantation or autologous hematopoietic stem cell transplantation.\n* Human Immunodeficiency Virus (HIV) infection, or active hepatitis infection (including tuberculosis, Hepatitis B Virus \\[HBV\\] and Hepatitis C Virus \\[HCV\\] infection),\n* History of other malignancies within 5 years prior to the first study drug administration. Exceptions include cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as Stage ≤ T2a, Gleason score ≤ 6, curatively treated at diagnosis with no biochemical recurrence of prostate-specific antigen \\[PSA; PSA ≤ 10 ng\u002FmL if tested\\]), carcinoma in situ of cervix or breast, and other malignancies deemed appropriate for study participation by the Investigator.\n* Females of childbearing potential with a positive pregnancy test or who are breastfeeding.\n* Psychiatric illnesses or disorders that may interfere with study compliance.\n* Any other conditions that render the participants unsuitable for study participation, as determined by the Investigator.\n\nExclusion Criteria for the Combination cohort with Docetaxel\n\n1. Prior exposure to taxane-based therapies.\n2. Received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days prior to the first dose (see Appendix 5).","ALL","18 Years",{"count":19,"type":20},108,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","For Safety introduction phase，this study is to evaluate the safety and tolerability of LM-168 in combination with other anti-tumor treatment regimens in participants of advanced solid tumor trials, determine the maximum tolerated dose (MTD), and explore the recommended phase II dose (RP2D).\n\nFor Dose expansion phase，this study is to evaluate the preliminary antitumor activity of LM-168 in combination with other antitumor treatment regimens in participants of advanced solid tumor trials, measured by objective response rate (ORR)",[26],"Advanced Solid Tumor","NOT_YET_RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":20},"2026-06-30",{"date":35,"type":20},"2028-12-15",{"name":37,"class":38},"LaNova Medicines Limited","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":39},"100620789","phase-3-lm-108-in-combination-with-toripalimab-versus-paclitaxel-injection-for-the-treatment-of-subjects-with-ccr8-positive-gastric-and-gastroesophageal-junction-adenocarcinoma-100620789","NCT07362186","LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma","A Phase III, Open-Label, Multicenter, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of LM-108 in Combination With Toripalimab Versus Paclitaxel Injection as Second-Line Therapy for CCR8-Positive Locally Advanced or Metastatic Gastric Cancer\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Individuals who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Age 18 years or older, male or female.\n3. Weight ≥ 40 kg or Body Mass Index (BMI)≥ 18.5 kg\u002Fm²\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n5. Life expectancy ≥ 3 months.\n6. Individuals must have histologically or cytologically confirmed locally advanced or metastatic gastric\u002Fgastroesophageal junction adenocarcinoma and be ineligible for curative surgery or radiotherapy.\n7. Confirmed CCR8-positive by the central laboratory.\n8. HER2-negative, low-expressing, or non-expressing.\n9. Individuals must experience radiographic progression during or after prior standard first-line therapy, or who developed intolerance to treatment due to chemotherapy-related toxicity\n10. At least one lesion.\n11. Have appropriate organ and marrow function in laboratory examinations.\n12. Women of childbearing potential have a negative pregnancy test and must not be breastfeeding. All of reproductive potential agree to use effective contraception throughout the study period and for 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Received treatment targeting the same target or other drugs acting on regulatory T cells (Tregs).\n2. Received antitumor treatments such as chemotherapy, radiotherapy, biological therapy, immunotherapy, or Chinese herbal medicine or Chinese herbal preparations within 2-4 weeks (depending on the specific anticancer drug) prior to the first dose.\n3. Received anti-PD-(L)1 antibody immunotherapy and experienced disease progression confirmed by RECIST 1.1 assessment within ≤2 months after treatment initiation.\n4. Use of any live vaccine within 4 weeks prior to the first dosing of study drugs.\n5. Individuals who received major surgery or interventional treatment within 4 weeks prior to the first dosing of study drugs.\n6. Individuals who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of study drugs.\n7. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0, individuals who experienced ≥ Grade 3 immune-related adverse events during prior immunotherapy, or terminated prior immunotherapy due to severe or life-threatening immune-related adverse events.\n8. Any other pathological type.\n9. Uncontrollable clinical third-space fluid accumulation.\n10. Unstable or progressive central nervous system (CNS) metastases or carcinomatous meningitis (meningeal metastases).\n11. Individuals with a known history of autoimmune diseases.\n12. For individuals with drug allergies or contraindications.\n13. The investigator determined that there are other situations that are not suitable for participation in this study.",{"count":48,"type":20},400,[50],"PHASE3","This is a phase III， Multicenter, Randomized study， evaluating the efficacy and Safety of LM-108(an Anti-CCR8 mAb) in combination With Toripalimab Versus Paclitaxel Injection in subjects with CCR8-Positive locally advanced or metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma.",[53],"Locally Advanced or Metastatic GC and GCJ Adenocarcinoma","RECRUITING","2026-05-06",{"date":57,"type":31},"2026-05-11",{"date":59,"type":31},"2026-04-30",{"date":61,"type":20},"2028-09-28",{"name":37,"class":38},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100622704","phase-2-phase-ii-study-of-lm-24c5-100622704","NCT07387081","Phase II Study of LM-24C5","An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of LM-24C5 in Combination With Other Anti-tumor Treatment in Subjects With CEACAM5-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Aged 18-80 years old (including boundary values) , male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Life expectancy ≥ 3 months.\n5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy.\n6. CEACAM5-positive subjects.\n7. At least one evaluable lesion.\n8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose.\n9. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.\n\nExclusion Criteria:\n\n1. Subjects with a history of other malignancies within 5 years prior to first dosing of LM-24C5, excluding cured squamous cell carcinoma of the skin, basal cell carcinoma, non-muscle-invasive bladder cancer, or localized low-risk prostate cancer, carcinoma in situ of the cervix\u002Fbreast, and other malignancies deemed by the investigator to potentially benefit from participation in this study.\n2. Subjects who have received other anti-tumor treatments before the first dosing of LM-24C5.\n3. Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis.\n4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n5. Present peripheral sensory or motor neuropathy ≥ grade 2.\n6. Subjects with uncontrolled pain.\n7. Subjects with symptomatic and untreated central nervous system metastases, and\u002For meningeal metastases.\n8. Subjects who have uncontrollable third space effusion.\n9. Previously received targeted therapy for same target.\n10. . Use of any live vaccines within 28 days prior to 1st dosing of IMP.\n11. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.\n12. Subjects on anticoagulants, such as heparin and vitamin K antagonists.\n13. Clinically uncontrollable persistent recurrent vomiting.\n14. Uncontrollable\u002Fsevere gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.\n15. Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of IMP.\n16. Subjects who have severe cardiovascular disease.\n17. Subjects who have uncontrolled or severe illness.\n18. Subjects who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.\n19. Subjects with a known history of autoimmune diseases.\n20. Subjects who have a history of immunodeficiency disease.\n21. Subjects with HIV infection, active HBV or HCV infection.\n22. Child-bearing potential female who have positive results in pregnancy. test within 7 days before the first dose or are lactating.\n23. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.\n24. Subject who is judged as not eligible to participate in this study by the investigator.","80 Years",{"count":72,"type":20},130,[23],"This study is to evaluate the efficacy and safety of the LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor",[76],"Advanced Solid Tumor Cancer","2026-01-27",{"date":79,"type":31},"2026-02-04",{"date":81,"type":31},"2025-12-15",{"date":83,"type":20},"2028-10-25",{"name":37,"class":38},2,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100601571","phase-1-a-study-of-lm-350-in-subjects-with-advanced-solid-tumours-100601571","NCT07112222","A Study of LM-350 in Subjects With Advanced Solid Tumours","A Phase I\u002FII, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-350 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Participant must be ≥18 years or the legal age of consent at the time of signing the ICF.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Life expectancy ≥ 3 months.\n5. Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.\n6. Pre-treatment archived tumour tissue (within 3 years) or on-treatment tumour biopsy could be provided for biomarker analysis.\n7. Must have at least one measurable lesion according to RECIST v1.1.\n8. Adequate organ and bone marrow function as defined by protocol.\n9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.\n\nExclusion Criteria:\n\n1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-350.\n2. Subjects who have received treatment with the same targeting.\n3. History of ≥ Grade 3 late diarrhea during or after previous treatment with a topoisomerase inhibitor.\n4. Subjects who have received the following anti-tumor treatments within the specified time periods prior to the first dosing of LM-350.\n5. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n6. Subjects with uncontrolled tumour-related pain.\n7. Subjects with known central nervous system (CNS) or meningeal metastasis.\n8. Subjects who have clinically uncontrollable third-space fluid accumulation.\n9. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.\n10. Subjects who take systemic corticosteroids (≥ 10 mg\u002Fday of prednisone or equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dose of LM-350.\n11. Has a history of (noninfectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n12. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, and any autoimmune, or prior pneumonectomy.\n13. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-350.\n14. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \\> 2 weeks prior to the first dose of LM-350.\n15. Subjects with active or a documented history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease).\n16. Subjects with complete or incomplete intestinal obstruction within 3 months prior to the first dose of the study drug , orpatients who are currently at the risk of intestinal perforation.\n17. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-350.\n18. Subjects who have severe cardiovascular disease.\n19. Subjects who have uncontrolled or severe illness.\n20. Subjects who have a history of immunodeficiency disease.\n21. HIV infection, active infection including tuberculosis, HBV and HCV infection.\n22. Subjects who have other active malignancies which are likely to require the treatment.\n23. Child-bearing potential female who have positive results in pregnancy test or are lactating.\n24. Subjects who have psychiatric illness or disorders that may preclude study compliance.\n25. Subject who is judged as not eligible to participate in this study by the investigator.",{"count":94,"type":20},80,[96,23],"PHASE1","For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-350 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explore the relationship between the biomarkers and the anti-tumor activity of LM-350.\n\nFor Phase II Dose Expansion Stage, to assess the preliminary anti-tumor activity of LM-350 in patients with advanced solid tumors.",[99],"Malignant Tumors","2026-01-22",{"date":102,"type":31},"2026-01-26",{"date":104,"type":31},"2025-08-28",{"date":106,"type":20},"2030-06-30",{"name":37,"class":38},4,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":39},"100568557","phase-1-a-phase-iii-study-of-lm-2417-in-subjects-with-advanced-solid-tumours-100568557","NCT06682780","A Phase I\u002FII Study of LM-2417 in Subjects With Advanced Solid Tumours","An Open-label, Dose-escalation, and Dose-expansion Phase I\u002FII Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Aged 18-80 years old (including boundary values) , male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Life expectancy ≥ 3 months.\n5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy.\n6. Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.\n7. At least one evaluable lesion.\n8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose.\n9. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug.\n10. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.\n\nSingle-agent dose of 6mg\u002Fkg, 12mg\u002Fkg and and combined cohort：Subjects tested positive for biomarkers.\n\nExclusion Criteria:\n\n1. Previously received with same target therapy.\n2. Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417.\n3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.\n4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n5. Poorly controlled tumor-related pain.\n6. Subjects with symptomatic\u002Factive central nervous system (CNS)metastases.\n7. Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n8. Subjects with known hypersensitivity to antibody therapy;\n9. Subjects who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) for more than 7 days or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-2417.\n10. Previous or current known autoimmune disease.\n11. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.\n12. Use of any live vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.;\n13. Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.\n14. Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of LM-2417.\n15. Subject who have history of severe cardiovascular disease.\n16. Subjects who have uncontrolled or severe illness.\n17. HIV infection, active HBV or HCV infection.\n18. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.\n19. Child-bearing potential female who have positive results in pregnancy test or are lactating.\n20. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.\n21. Subject who is judged as not eligible to participate in this study by the investigator.",{"count":117,"type":20},320,[96,23],"This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)\u002For Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.",[26],"2025-09-21",{"date":123,"type":31},"2025-09-25",{"date":125,"type":31},"2025-09-17",{"date":127,"type":20},"2029-12-01",{"name":37,"class":38},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100530486","phase-1-a-study-of-lm-24c5-for-advanced-solid-tumors-100530486","NCT06187402","A Study of LM-24C5 For Advanced Solid Tumors","A Phase I\u002FII, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-24C5 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any study related procedures.\n2. Aged ≥18 years old when sign the ICF, male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.\n4. Life expectancy ≥ 3 months.\n5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.\n6. Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum requirements.\n7. At least one measurable lesion according to RECIST v1.1.\n8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.\n9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.\n\nExclusion Criteria:\n\n1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5.\n2. Any prior treatments towards the investigational target.\n3. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits.\n4. Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of CTCAE v5.0.\n5. Subjects with uncontrolled pain.\n6. Subjects with known central nervous system (CNS) or meningeal metastasis.\n7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n8. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains any monoclonal antibody.\n9. Subjects who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-24C5.\n10. Subjects with the known history of autoimmune disease.\n11. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n12. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C5.\n13. Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists for presence of active thromboembolic disease.\n14. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-24C5.\n15. Subjects who have severe cardiovascular disease.\n16. Subjects who have uncontrolled or severe illness, including but not limited to ongoing or active infection\n17. Subjects who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.\n18. HIV infection, active infection including tuberculosis, HBV and HCV infection, with the exception:\n19. Subjects who have other active malignancies which are likely to require the treatment.\n20. Child-bearing potential female who have positive results in pregnancy test or are lactating.\n21. Subjects who have psychiatric illness or disorders that may preclude study compliance.\n22. Subject who is judged as not eligible to participate in this study by the investigator.",{"count":137,"type":20},49,[96,23],"To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)\u002Foptimal biologic dose (OBD) and\u002For Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors.",[26],"2025-09-07",{"date":143,"type":31},"2025-09-09",{"date":145,"type":31},"2023-12-20",{"date":147,"type":20},"2026-12-30",{"name":37,"class":38},6,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":149},"100582814","phase-1-a-study-of-lm-168-as-a-single-agent-or-in-combination-with-toripalimab-in-subjects-with-advanced-solid-tumours-100582814","NCT06868199","A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours","A Phase I\u002FII, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Aged ≥18 years old (including boundary values) , male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Life expectancy ≥ 3 months.\n5. In dose escalation stage, subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.\n6. In dose expansion stage, subjects must have histological or cytological confirmation of selected advanced solid tumors.\n7. Pre-treatment archived tumour tissue or on-treatment tumour biopsy could be provided for biomarker analysis optionally.\n8. At least one measurable disease.\n9. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.\n10. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.\n\nExclusion Criteria:\n\n1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-168.\n2. Having received prior anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with LM-168 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n3. Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.\n4. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n5. Subjects with uncontrolled tumour-related pain.\n6. Subjects with known central nervous system (CNS) or meningeal metastasis.\n7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n8. Subjects with esophageal or gastric varices requiring immediate intervention, or those with a history of variceal bleeding.\n9. Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe liver cirrhosis.\n10. Tumor invasion of surrounding vital organs or a risk of developing esophagotracheal fistula or esophagopleural fistula.\n11. Patients with a history of active or previously confirmed inflammatory bowel disease.\n12. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.\n13. Subjects who previously experienced grade ≥ 3 immune-related adverse events during immunotherapy, as well as subjects who discontinued prior immunotherapy due to severe or life-threatening immune-related adverse events.\n14. Subjects who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-168.\n15. Subjects with the known history of autoimmune disease.\n16. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, interstitial lung disease, severe radiation pneumonitis or evidence of active pneumonitis on screening chest CT scan.\n17. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-168.\n18. Current or recent use of aspirin (\\> 325 mg\u002Fday) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.\n19. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \\> 2 weeks prior to the first dose of LM-168.\n20. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-168 (excluding tumour biopsy, puncture, etc.).\n21. Subjects who have severe cardiovascular disease.\n22. Subjects who have uncontrolled or severe illness.\n23. Subjects who have a history of immunodeficiency disease.\n24. HIV infection, active infection including tuberculosis, HBV and HCV infection.\n25. Subjects with a history of other malignancies within 5 years prior to the first administration of the study drug.\n26. Child-bearing potential female who have positive results in pregnancy test or are lactating.\n27. Subjects who have psychiatric illness or disorders that may preclude study compliance.\n28. Subject who is judged as not eligible to participate in this study by the investigator.",{"count":158,"type":20},87,[96,23],"For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and\u002For Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours.\n\nFor phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.",[162],"Advanced Solid Tumours","2025-09-06",{"date":165,"type":31},"2025-09-12",{"date":167,"type":31},"2025-05-06",{"date":169,"type":20},"2028-02-01",{"name":37,"class":38},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":178,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":149},"100566083","phase-1-study-of-lm-299-in-subjects-advanced-malignant-tumors-100566083","NCT06650566","Study of LM-299 in Subjects Advanced Malignant Tumors","A Phase I\u002FII, Open-label, Dose Escalation and Dose Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LM-299 Injection as Monotherapy or in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Participant must be 18- 18 years or the legal age of consent at the time of signing the ICF.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Life expectancy ≥ 3 months.\n5. Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.\n6. Pre-treatment archived tumour tissue (within 5 years) or fresh samples could be provided for biomarker analysis.\n7. Must have at least one measurable lesion according to RECIST v1.1.\n8. Adequate organ and bone marrow function as defined by protocol.\n9. Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception.\n10. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.\n\nExclusion Criteria:\n\n1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-299.\n2. Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-299.\n3. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n4. Subjects with uncontrolled tumour-related pain.\n5. Subjects with known central nervous system (CNS) or meningeal metastasis.\n6. Qualitative urine protein results ≥ 3+.\n7. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to 1st dosing of LM-299.\n8. Any life-threatening bleeding event that occurred within 3 months prior to 1st dosing of LM-299.\n9. Subjects with esophageal or gastric varices requiring immediate intervention or a history of variceal bleeding .\n10. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis.\n11. Subjects who have clinically uncontrollable third-space fluid accumulatio.\n12. Radiographic evidence of tumor invading surrounding vital organs or the risk of esophagotracheal fistula or esophagopleural fistula, tumor surrounding or invading the major blood vessels, or presence of intratumoral cavity formation.\n13. History of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of the study drug.\n14. Patients with complete or incomplete intestinal obstruction within 3 months prior to the first dose of the study drug or patientswho are currently at the risk of intestinal perforation.\n15. Subjects who are known to be allergic to antibody treatment.\n16. Subjects who take systemic corticosteroids (≥ 10 mg\u002Fday of prednisone or equivalent) for more than 7 days within 2 weeks prior to the first dose of LM-299.\n17. Subjects with the known history of autoimmune disease.\n18. Patients with a history of active or previously confirmed inflammatory bowel disease.\n19. Patients with a history of or currently having interstitial pneumonia requiring systemic corticosteroid treatment.\n20. Received live vaccines or attenuated live vaccines within 28 days prior to the first dose of the study drug.\n21. Currently using anticoagulants such as therapeutic doses of heparin or vitamin K antagonists.\n22. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-299 (excluding tumour biopsy, puncture, etc.).\n23. Subjects who have severe cardiovascular and and cerebrovascular diseases.\n24. Patients with severe infections within 4 weeks prior to the first dose.\n25. Patients with a history of immunodeficiency.\n26. Individuals with HIV infection, active HBV or HCV infection .\n27. Patients with known active tuberculosis (TB). Suspected active TB should be ruled out through clinical examination.\n28. Patients who have had other malignancies within 5 years prior to the first dose of the study drug.\n29. Women of childbearing age who test positive for pregnancy within 7 days prior to the first dose of the study drug or are breastfeeding.\n30. Individuals with known psychiatric disorders or illnesses that may affect adherence to the trial.\n31. Patients with local or systemic diseases caused by non-malignant tumors.\n32. Subject who is judged as not eligible to participate in this study by the investigator.",{"count":19,"type":20},[96,23],"For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours..\n\nFor Phase II Dose Expansion Stage, to assess the antitumor activity of LM-299 in patients with various advanced solid tumors.",[99],"2025-04-29",{"date":184,"type":31},"2025-05-02",{"date":186,"type":31},"2024-10-09",{"date":188,"type":20},"2027-07",{"name":37,"class":38},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":39},"100583248","phase-2-a-study-of-lm-108-in-combination-with-toripalimab-in-subjects-with-advanced-solid-tumours-100583248","NCT06873854","A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours","Evaluation of a Phase II, Single-arm, Multicenter, Open-label Clinical Study on LM-108 Injection in Combination With Toripalimab for Advanced Malignant Solid Tumors in Patients With Unresectable or Metastatic Microsatellite Highly Unstable (MSI H) or Mismatch Repair Defects (dMMR) Who Have Failed Previous Treatment With Anti-PD-1\u002FPD-L1 Drugs","Inclusion Criteria:\n\n1. Subjects with advanced solid tumors diagnosed by pathology have evidence of advanced stage or metastasis that cannot be surgically removed. And the MSI-H status will be confirmed by central laboratory designated of the sponsor.\n2. Aged 18.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. At least one measurable lesion.\n5. Subjects who have failed previous monotherapy with anti-PD-1\u002FPD-L1 drugs or combination (synchronous or sequential) with other systemic treatments and unresectable or metastatic late stage MSI-H\u002FdMMR solid tumors.\n6. Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.\n7. Any adverse event from prior anti-tumor therapy and surgery has recovered to ≤ grade 1 of CTCAE v5.0.\n8. Subjects must show appropriate organ and marrow function in laboratory examinations.\n9. Women of childbearing potential (WOCBP) and Male participants must agree to use one medically recognized contraceptive measures of contraception, during the study and for 6 months after the last dose of study drug.\n10. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n\nExclusion Criteria:\n\n1. Subjects with symptomatic\u002Factive central nervous system (CNS) metastases.\n2. Subject who have uncontrollable pleural effusion, pericardial effusion, and ascites despite treatment such as puncture and drainage Within 14 days prior to enrollment; Pericardial effusion accompanied by clinical symptoms or moderate or above.\n3. Subjects' weight decreased by more than 20% within the first 2 months of enrollment.\n4. Poorly controlled tumor-related pain.\n5. Subjects who received anti-tumour treatment, , major surgery, immunosuppressive drugs and live attenuated vaccines before enrollment.\n6. Subjects have received anti-tumor immunotherapy and experienced ≥ grade 3 immune related adverse events (irAE) or ≥ grade 2 immune related myocarditis.\n7. Subjects who have other cancers within 5 years prior to entering the research.\n8. Previous or current known autoimmune disease.\n9. Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies; Arterial\u002Fvenous thrombotic events that occurred within the first 6 months of enrollment.\n10. Present peripheral neuropathy of grade\\>1 .\n11. Subjects who have a history of gastrointestinal perforation and\u002For gastrointestinal fistula within the 6 months prior to enrollment.\n12. Subjects who have been clinical signs or symptoms of intestinal obstruction and\u002For gastrointestinal obstruction Within 6 months prior to starting the study treatment.\n13. Presence of interstitial lung disease, non infectious pneumonia, or uncontrolled systemic diseases.\n14. Known to be allergic to the investigational drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies.\n15. HIV infection, active HBV or HCV infection.\n16. Subject who have clinical symptoms or diseases of the heart that have not been well controlled.\n17. Subjects who take Systemic use of antibiotics for more than 7 days within the first 4 weeks prior to enrollment, or unexplained fever\\>38.5 ° C during screening\u002Fbefore first administration .\n18. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n19. Subjects who have participated in any other drug clinical studies within 4 weeks prior to enrollment, or have not exceeded 5 half lives since the last study medication.\n20. Known history of abuse or drug use of psychotropic substances.\n21. Subjects who have other serious physical or mental illnesses or laboratory abnormalities and judged as not eligible to participate in this study by the investigator.",{"count":198,"type":20},84,[23],"Based on overall response rate (ORR) as assessed by the Independent Review Committee (IRC) against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria for Solid Tumor Efficacy, To evaluate the efficacy of LM-108 in combination with Toripalimab in patients with advanced malignant solid tumours with unresectable or metastatic MSI-H\u002FdMMR who have failed previous anti-PD-1 \u002FPD-L1 therapy.",[26],"2025-03-10",{"date":204,"type":31},"2025-03-13",{"date":206,"type":20},"2025-03-26",{"date":208,"type":20},"2030-01-26",{"name":37,"class":38},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100486584","phase-1-a-phase-iii-study-of-lm-101-injection-in-patients-with-advanced-malignant-tumors-100486584","NCT05615974","A Phase I\u002FII Study of LM-101 Injection in Patients With Advanced Malignant Tumors","A Phase I\u002FII, Open-label, Dose Escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of LM-101 Injection as a Single Agent or Combination Therapy in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Aged ≥18 years old, male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Life expectancy ≥ 3 months.\n5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy.\n6. At least one evaluable lesion.\n7. Subjects in the combination therapy group must have Archived Samples or fresh tumor tissue specimens are required for testing.\n8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:\n9. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug.\n10. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.\n\nExclusion Criteria:\n\n1. Subject has received prior investigational therapy directed at the same target therapy.\n2. Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-101.\n3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.\n4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n5. Poorly controlled tumor-related pain.\n6. Subjects with symptomatic\u002Factive central nervous system (CNS) metastases.\n7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n8. Subjects with known hypersensitivity to antibody therapy.\n9. Subjects who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medicationswithin 2 weeks prior to the first dosing of LM-101.\n10. Subjects with the known history of autoimmune disease with the exception of subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone.\n11. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.\n12. Use of any live attenuated vaccines within 28 days prior to the first dosing of LM-101.\n13. Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.\n14. Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.).\n15. Subjects who have history of severe cardiovascular disease.\n16. Subjects who have uncontrolled or severe illness.\n17. Subjects who have a history of immunodeficiency disease.\n18. HIV infection, active tuberculosis or active HBV and HCV infection.\n19. Subjects who have Known history of active tuberculosis.\n20. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.\n21. Child-bearing potential female who have positive results in pregnancy test or are lactating.\n22. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.\n23. Subject who is judged as not eligible to participate in this study by the investigator.",{"count":218,"type":20},139,[96,23],"This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and\u002For the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors",[99],"2024-12-16",{"date":224,"type":31},"2024-12-19",{"date":226,"type":31},"2023-01-11",{"date":228,"type":20},"2028-01-11",{"name":37,"class":38},5,""]