[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Multitude Therapeutics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,65,87,109,131],{"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},"100546862","early-phase-1-amt-676-in-patients-with-advanced-solid-tumors-100546862",false,"NCT06400485","AMT-676 in Patients With Advanced Solid Tumors","First-in-Human, Phase I\u002FII Study of AMT-676, an Anti CDH17 Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Patients must be willing and able to sign the ICF, and to adhere to the study visit Schedule and other protocol requirements.\n2. Age ≥18 years (at the time consent is obtained).\n3. Patients with pathologically confirmed unresectable advanced solid tumor. Preferred tumor types include colorectal cancer, gastric cancer, esophageal adenocarcinoma, cholangiocarcinoma, pancreatic ductal cancers, and neuroendocrine tumors.\n4. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.\n5. Patients must have at least one measurable lesion as per RECIST version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. Life expectancy ≥3 months.\n8. Patients must have adequate organ function\n9. Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.\n10. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 6months after the last dose of the IMP.\n11. Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 3 months and 6 months, respectively after the last dose of the IMP.\n12. Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.\n\nKey Exclusion Criteria:\n\n1. Prior treatment with any agent for the same target or ADC based on topoisomerase I inhibitor.\n2. Central nervous system (CNS) metastasis\n3. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.\n4. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1.\n5. Systemic anti-neoplastic therapy within five half-lives or21 days, whichever is shorter, prior to first dose of the IMP.\n6. Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., \\>30% of marrow-bearing bones) within 28 days.\n7. Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.\n8. Significant cardiac disease, such as recent (within months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg), uncontrolled cardiac arrhythmias.\n9. Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, etc.) or other lung disease significantly impacting lung function at baseline.\n10. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.\n11. Acute and\u002For clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV)\n12. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.\n13. Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment.\n14. Known or suspected severe allergy\u002Fhypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.\n15. Known or suspected intolerance to the components of the IMP.\n16. Concurrent participation in another investigational therapeutic clinical trial.\n17. Patients with known active alcohol or drug abuse.\n18. Pregnant or breast-feeding females\n19. Mental or medical conditions that prevent the patient from giving informed consent or complying with the trial or other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the IMP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrolment in this study.\n20. Prior history of malignancy other than inclusion diagnosis within five years prior to first dose of the IMP.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is a first-in-human, open-label, multicenter Phase Ia\u002FIb study of AMT- 676, followed by an open-label, multicenter, dose-escalation.",[26],"Advanced Solid Tumors","RECRUITING","2026-05-14",{"date":30,"type":31},"2026-05-18","ACTUAL",{"date":33,"type":31},"2024-06-18",{"date":35,"type":20},"2027-12-31",{"name":37,"class":38},"Multitude Therapeutics Inc.","INDUSTRY",13,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":64},"100638296","phase-1-amt-116-in-combination-with-ivosidan-in-patients-with-lung-cancer-100638296","NCT07590531","AMT-116 in Combination With Ivosidan in Patients With Lung Cancer","An Open-label, Multicenter Phase Ib\u002FII Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMT116 in Combination With Ivosimab (AK112) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)","Key Inclusion Criteria:\n\n1. Willing and able to provide written informed consent for this trial.\n2. At the time of screening, aged ≥18 years and ≤75 years.\n3. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIII C) or metastatic (Stage IV) NSCLC that is not amenable to complete surgical resection and cannot be treated with curative concurrent or sequential chemoradiotherapy (according to the 8th edition of the International Union Against Cancer and the American Joint Committee on Cancer TNM staging for lung cancer).\n4. Stage Ib: Locally advanced\u002Fmetastatic NSCLC; both subjects who have previously received systemic therapy and those who have not may be enrolled;\n\n   Phase II: Each cohort must meet the following requirements:\n\n   Cohort 1: Histologically or cytologically diagnosed with non-squamous NSCLC, EGFR wild-type, and ALK fusion-negative.\n\n   Co-hort 2: Histologically or cytologically diagnosed with squamous-cell NSCLC, known to be EGFR wild-type and ALK fusion gene-negative.\n\n   Co-hort 3: Histologically or cytologically diagnosed with non-squamous NSCLC and harboring an EGFR mutation.\n5. Subjects must have at least one measurable lesion (as defined by RECIST 1.1 criteria).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Expected survival of ≥12 weeks.\n8. Subjects' laboratory test results must meet the requirements.\n9. Women of child-bearing potential (WCBP) must consent to the use of two effective contraceptive methods during the study treatment period and for at least 12 weeks after the final administration of IMP\n10. Women of child-bearing potential (WCBP) must have a negative serum pregnancy test within seven days preceding the initial administration of the investigational medicinal product (IMP).\n11. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n12. Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n\nKey Exclusion Criteria:\n\n1. Histopathological evidence of small cell lung cancer.\n2. For Cohort 1 and Cohort 2 of Phase II, patients must not have non-small cell lung cancer with known EGFR-sensitive mutations, ALK fusions, BRAF V600E mutations, ROS1 fusions, MET exon 14 skipping mutations, NTRK fusions, or RET fusions.\n3. Prior treatment with any CD44v9-targeted therapy or an antibody-drug conjugate (ADC) based on a topoisomerase I inhibitor as the toxin.\n4. Received the following treatments or medications prior to the start of the study:\n\n   i. Systemic anticancer therapy, including chemotherapy and biologics, within 3 weeks prior to the first dose; hormonal anticancer therapy or small-molecule targeted therapy within 2 weeks prior to the first dose; or Chinese herbal medicines or proprietary Chinese herbal preparations with anticancer indications within 2 weeks prior to the first dose. Received nonspecific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor, etc.) within 2 weeks prior to the first dose.\n\n   ii. Received a live or attenuated vaccine within 4 weeks prior to the first dose.\n\n   iii. Received radiation therapy within 3 weeks prior to the first dose. Palliative radiation therapy administered for symptom control at least 2 weeks prior to the first dose is permitted.\n5. Received systemic immunosuppressive therapy (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 2 weeks prior to the first dose.\n6. Adverse reactions from prior treatment have not yet resolved to Grade 1 or less.\n7. Subjects who have experienced an immune-related adverse event (irAE) requiring permanent discontinuation of treatment, or a Grade 3 or higher irAE, or a cardiac, neurological, or ocular irAE of any grade (including Grade 2 immune-related pneumonia, but excluding Grade 3 hypothyroidism that can be controlled with hormone replacement therapy).\n8. Known symptomatic brain metastases or other central nervous system (CNS) metastases, or brain metastases or other CNS metastases that the investigator deems to require treatment but have not been treated. Subjects with asymptomatic brain metastases or a history of brain metastases that have been stable for ≥2 weeks prior to the first dose may be eligible for this study, provided they meet all of the following criteria: no metastases to the meninges, midbrain, pons, cerebellum, medulla oblongata, or spinal cord, or spinal cord compression; discontinuation of hormonal therapy for more than 2 weeks prior to the first dose; imaging studies performed within at least 4 weeks show no evidence of new or enlarged brain metastases.\n9. History of malignancy other than the enrollment diagnosis within 5 years prior to the first administration of the study drug.\n10. Underwent major surgery within 4 weeks prior to the first administration of the study drug, or has not fully recovered from surgery; or sustained a major traumatic injury within 4 weeks prior to the first administration; or is scheduled to undergo surgery during the anticipated duration of study participation or within 4 weeks after the last administration.\n11. History of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy; current ILD\u002Fpneumonia; suspected ILD\u002Fpneumonia (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, etc.); or other pulmonary diseases that significantly impair lung function at baseline.\n12. History of active autoimmune disease or a history of autoimmune disease requiring systemic treatment within the past 2 years.\n13. Current or past history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).\n14. History of hypertensive crisis or hypertensive encephalopathy.\n15. Subjects with severe coagulation disorders or other evidence of significant bleeding risk.\n16. Uncontrolled pleural effusion or ascites requiring repeated drainage within 4 weeks prior to the first dose.\n17. Active infection treated with systemic antimicrobial therapy within 2 weeks prior to the first dose. Severe infection occurring within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.\n18. History of abdominal fistula, tracheoesophageal fistula, or female genital fistula (e.g., vesicovaginal fistula, ureterovaginal fistula, and vesicovaginal fistula), gastrointestinal perforation, or abdominal abscess; or if the investigator considers the subject to have risk factors for gastrointestinal obstruction. If the fistula or perforation has been treated by resection or repair, and the investigator assesses that the condition has fully resolved, the subject may be enrolled.\n19. The subject has uncontrolled comorbidities, including but not limited to poorly controlled hypertension or diabetes, psychiatric disorders, or conditions that may limit study compliance, or other comorbidities or conditions that the investigator believes may affect study judgment or interfere with the completion of study procedures and follow-up examinations.\n20. Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.\n21. Patients who are positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis C virus (HCV) antibodies at screening are ineligible for enrollment, unless hepatitis B virus (HBV) DNA levels and HCV RNA testing clearly rule out active infection requiring antiviral treatment for hepatitis B or C (HBV DNA ≥ 1000 cps\u002FmL or 200 IU\u002FmL).\n22. Known active tuberculosis (TB); suspected active tuberculosis must be ruled out by clinical examination.\n23. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, excluding corneal transplantation.\n24. Known immediate-type or delayed-type hypersensitivity to the study drug, a history of allergic reactions, or allergy to any component of the study drug or excipients.\n25. Pregnancy (positive β-human chorionic gonadotropin \\[β-hCG\\] test) and lactating women.\n26. The subject is unwilling or unable to comply with the protocol.\n27. The subject requires the use of a potent CYP3A4 inhibitor within one week prior to dosing or during the study.\n28. Any other disease, metabolic disorder, physical examination findings, or clinical laboratory results that raise suspicion of contraindications to the study drug, or that may affect the subject's safety, the interpretation of study results, or place the subject at high risk of complications.\n\n    \\-","75 Years",{"count":49,"type":20},118,[51,52],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with ivosidan (AK112) in patients with advanced non-small cell lung cancer (NSCLC). The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.",[55],"Advanced Non-small Cell Lung Cancer (NSCLC)","NOT_YET_RECRUITING","2026-05-10",{"date":59,"type":31},"2026-05-15",{"date":61,"type":20},"2026-05-01",{"date":35,"type":20},{"name":37,"class":38},2,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100629442","phase-2-a-phase-ii-study-of-amt-676-combination-therapies-in-advanced-colorectal-cancer-100629442","NCT07474727","A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer","An Phase II Study Evaluating the Safety and Efficacy of AMT-676 in Combination With 5-fluorouracil, Leucovorin, Bevacizumab (or Cetuximab) in Participants of Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements\n* Patients with pathologically confirmed, unresectable advanced colorectal adenocarcinoma\n* Patients must have at least one measurable lesion as per RECIST version 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy ≥6 months\n* Patients must have adequate organ function\n* Male and female individuals with child bearing potential must agree to take effective contraceptive measures from the moment they sign the informed consent form until 6 months after the last administration of the study drug\n* WCBP(Women of Child-Bearing Potential) must have a negative serum pregnancy test within 7 days prior to first dose of the IMP\n* Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 3 months and 6 months, respectively, after the last dose of the IMP(Investigational Medicinal Product)\n* Availability of tumor tissue sample\n\nExclusion Criteria:\n\n* Prior treatment with any same target\n* Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP\n* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1\n* Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention, or a surgery is planned to be conducted within the expected participation period of the trial or within 4 weeks after the last administration of the drug\n* History of thromboembolic or cerebrovascular events during last 6 mouths\n* During the three months prior to the first administration of the drug, there were any life-threatening bleeding events, or grade 3 or higher gastrointestinal\u002Fvenous variceal bleeding events that required blood transfusion, endoscopy, or surgical treatment. Or there were other diseases that the researchers believed posed a higher risk of bleeding or thrombosis during the study period\n* Has a history of interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis , or other lung disease significantly impacting lung function at baseline.\n* Any other concurrent diseases or conditions that could affect the research judgment or impede the completion of the research procedures and follow-up checks\n* Central nervous system (CNS) metastasis\n* Have a history of active or acute diverticulitis, abdominal abscess, gastrointestinal obstruction, fistula, or peritoneal cancer\n* Any evidence indicates severe or uncontrolled systemic diseases\n* Acute and\u002For clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).\n* Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP\n* Patients requiring concurrent treatment of strong\u002Fmoderate inhibitors or strong inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment\n* Known or suspected severe allergy\u002Fhypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies\n* Known or suspected intolerance to the components of the IMP\n* Concurrent participation in another investigational therapeutic clinical trial\n* Pregnant or breast-feeding females\n* Investigator determined that the trial participants who were not suitable to participate in this study for other reasons","80 Years",{"count":74,"type":20},180,[52],"This study is an open, multi-center, phase II study, aiming to evaluate the safety, tolerability and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, bevacizumab (or cetuximab) in participants with advanced colorectal cancer, and to assess the PK(Pharmacokinetic) characteristics and immunogenicity of AMT-676.",[78],"Colorectal Cancer","2026-03-11",{"date":81,"type":31},"2026-03-16",{"date":83,"type":20},"2026-04-01",{"date":85,"type":20},"2028-02-28",{"name":37,"class":38},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100532190","phase-1-amt-253-in-patients-with-advanced-solid-tumours-100532190","NCT06209580","AMT-253 in Patients With Advanced Solid Tumours","Phase I\u002FII Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.\n* 2\\. Patients with histologically confirmed melanoma or other advanced solid tumor.\n* 3\\. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.\n* 4\\. Patients must have at least one measurable lesion as per RECIST version 1.1.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* 6\\. Life expectancy ≥ 3 months.\n* 7\\. Patients must have adequate organ function\n* 8\\. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.\n* 9\\. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.\n* 10\\. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.\n* 11\\. Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n* 12\\. Availability of tumor tissue sample at screening.\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with any agent that has the same target.\n* 2\\. Central nervous system (CNS) metastasis.\n* 3\\. Active or chronic skin disorder requiring systemic therapy.\n* 4\\. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.\n* 5\\. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1.\n* 6\\. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.\n* 7\\. Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.\n* 8\\. Significant cardiac disease, such as recent myocardial infarction or acute coronary syndromes, congestive heart failure， uncontrolled hypertension, uncontrolled cardiac arrhythmias.\n* 9\\. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.\n* 10\\. Acute and\u002For clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).\n* 11\\. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.",{"count":95,"type":20},96,[51,52],"This is a non-randomized, open-label, multicenter Phase I\u002FII study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.",[99,26],"Malignant Melanoma","2025-08-28",{"date":102,"type":31},"2025-09-05",{"date":104,"type":31},"2024-01-31",{"date":106,"type":20},"2026-12-31",{"name":37,"class":38},1,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100494985","phase-1-amt-116-in-patients-with-advanced-solid-tumors-100494985","NCT05725291","AMT-116 in Patients With Advanced Solid Tumors","First-in-Human, Phase 1 Study of AMT-116 in Patients With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.\n* Age ≥18 years (at the time consent is obtained).\n* Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.\n* Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.\n* Patients must have at least one measurable lesion as per RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Both male and female patients must agree to use effective contraceptive methods.\n* Patients must have adequate organ function.\n* Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.\n* Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n* Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n* Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.\n\nKey Exclusion Criteria:\n\n* Prior therapy with ADC based on Top1 inhibitor.\n* Central nervous system (CNS) metastasis.\n* Active or chronic skin disorder requiring systemic therapy.\n* History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.\n* Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.\n* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1.\n* Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.\n* Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., \\> 30% of marrow-bearing bones) within 28 days.\n* Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.\n* Prior allogeneic or autologous bone marrow transplantation.\n* Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.\n* Pregnant or breast-feeding females.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":117,"type":20},80,[51],"This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) \u002F the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in Patients with Advanced Solid Tumors",[121],"Advanced Solid Tumor","2025-08-13",{"date":124,"type":31},"2025-08-17",{"date":126,"type":31},"2023-07-25",{"date":128,"type":20},"2026-12-30",{"name":37,"class":38},10,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":149,"locationsCount":150},"100576210","phase-1-amt-116-in-patients-with-solid-tumors-100576210","NCT06782334","AMT-116 in Patients with Solid Tumors","Phase 1\u002F2 Study of AMT-116 in Patients with Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.\n2. Age ≥18 years (at the time consent is obtained).\n3. Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include non-small cell lung, head and neck, esophageal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.\n4. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.\n5. Patients must have at least one measurable lesion as per RECIST version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. The anticipated survival duration is no less than three months.\n8. Patients must have adequate organ function\n9. Women of child-bearing potential (WCBP) must consent to the use of two effective contraceptive methods during the study treatment period and for at least 12 weeks after the final administration of IMP\n10. Women of child-bearing potential (WCBP) must have a negative serum pregnancy test within seven days preceding the initial administration of the investigational medicinal product (IMP).\n11. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n12. Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.\n13. Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.\n\nExclusion Criteria:\n\n1. Prior therapy with ADC based on Top1 inhibitor.\n2. Central nervous system (CNS) metastasis.\n3. Active or chronic skin disorder requiring systemic therapy.\n4. History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.\n5. Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.\n6. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1.\n7. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.\n8. Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., \\> 30% of marrow-bearing bones) within 28 days.\n9. Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.\n10. Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.\n11. Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, etc.).\n12. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.\n13. Acute and\u002For clinically significant bacterial, fungal or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV).\n14. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.\n15. Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment.\n16. Known or suspected severe allergy\u002Fhypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.\n17. Known or suspected intolerance to the components of the IMP.\n18. Concurrent participation in another investigational therapeutic clinical trial.\n19. Patients with known active alcohol or drug abuse.\n20. Pregnant or breast-feeding females.\n21. Mental or medical disorders that prevent patients from signing informed consent or complying with the study, or other severe acute or chronic medical or psychiatric disorders or abnormal laboratory results that may increase the risk associated with study participation or IMP administration or may interfere with the interpretation of study results and, in the investigator's judgment, make patients ineligible for enrollment in the study.\n22. There was a history of malignant tumors other than the selected diagnosis within 5 years prior to the first administration of IMP",{"count":139,"type":20},144,[51,52],"The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.",[26],"2025-01-16",{"date":145,"type":31},"2025-01-17",{"date":147,"type":31},"2024-05-07",{"date":128,"type":20},{"name":37,"class":38},7,""]