[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Myeloid Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,82],{"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":27,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100618630","phase-1-safety-pharmacokinetics-pharmacodynamics-and-preliminary-efficacy-of-mt-304-in-adults-with-advanced-her2-expressing-solid-tumors-100618630",false,"NCT07334119","Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors","A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n* Aged 18 years or above\n* Histologically confirmed diagnosis of metastatic or advanced epithelial cancer expressing HER2 (Note: Participants with other tumor types expressing HER2 may be considered pending discussion with the Medical Monitor).\n* Measurable lesion per RECIST 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1.\n* Adequate Organ function\n\nExclusion Criteria:\n\n* Known active CNS metastasis and\u002For carcinomatous meningitis.\n* Any acute illness including fever.\n* History of symptomatic congestive heart failure\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites\n* Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-304 in adults with advanced HER2-expressing solid tumors. The main questions it aims to answer are:\n\n* What is the safety profile of MT-304 when administered alone or with nivolumab?\n* What is the recommended Phase 2 dose (RP2D) of MT-304?\n\nParticipants will:\n\n* Receive MT-304 alone (every 14 days) or with nivolumab (every 28 days).\n* Attend regular clinic visits for assessments and monitoring.\n* Continue treatment until disease progression, unacceptable toxicity, or study discontinuation.",[26],"HER2-Expressing Solid Tumors",[28,29,30,31,32,33,34,35,36,37,38,39,40],"Anti-HER2 chimeric antigen receptor","Chimeric Antigen Receptor (CAR)","mRNA","Lipid nanoparticle (LNP)","Urothelial carcinoma","Endometrial carcinoma","Ovarian epithelial carcinoma","Breast carcinoma (all subtypes)","Gastric adenocarcinoma","Esophageal adenocarcinoma","Non-small cell lung cancer","Colorectal carcinoma","Biliary cancer (including Gallbladder carcinoma and extrahepatic cholangiocarcinoma)","RECRUITING","2026-05-18",{"date":44,"type":45},"2026-05-20","ACTUAL",{"date":47,"type":45},"2025-11-25",{"date":49,"type":20},"2028-03-30",{"name":51,"class":52},"Myeloid Therapeutics","INDUSTRY",7,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100552869","phase-1-a-study-of-mt-303-in-adults-with-advanced-or-metastatic-gpc3-expressing-cancers-including-hcc-100552869","NCT06478693","A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC","A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including Hepatocellular Carcinoma","Inclusion Criteria\n\n* Aged 18 years or older\n* Histological diagnosis of advanced\u002Frecurrent or metastatic and\u002For unresectable HCC. \\[Note: participants with other tumor types expressing GPC3 may be eligible for Module 1 pending a discussion with the Medical Monitor. Only participants with HCC are eligible for Module 2.\n* Measurable lesion per RECIST 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1\n* Child-Pugh score: Class A\n* Adequate organ function\n\nGeneral Exclusion Criteria\n\n* Known active CNS metastasis and\u002For carcinomatous meningitis.\n* Any acute illness including active infection\n* History of liver transplantation or on waiting list\n* Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding\n* Uncontrolled pleural effusion, pericardial effusion, or ascites\n* History of symptomatic congestive heart failure\n* History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.\n\nAdditional Module 2 Exclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* Significant cardiovascular disease\n* History of severe hypersensitivity to atezolizumab and\u002For bevacizumab.\n* History of idiopathic pulmonary fibrosis\n* Prior history of hypertensive crisis or hypertensive encephalopathy.",{"count":62,"type":20},70,[23],"This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 alone (Module 1) and in combination with Atezo\u002FBev (Module 2) in participants with advanced hepatocellular carcinoma expressing GPC3.",[66],"Hepatocellular Carcinoma",[68,69,70,71,72],"Liver Cancer","Hepatocellular Carcinoma (HCC)","Glypican-3","Chimeric antigen receptor","CAR-M","2025-12-11",{"date":75,"type":45},"2025-12-18",{"date":77,"type":45},"2024-07-01",{"date":79,"type":20},"2028-05-31",{"name":51,"class":52},9,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100513712","phase-1-study-of-mt-302-in-adults-with-advanced-or-metastatic-epithelial-tumors-100513712","NCT05969041","Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors","MYE Symphony: A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors","MYE Symphony","Inclusion Criteria:\n\n1. Adults age ≥ 18 inclusive at the time the Informed Consent Form (ICF) is signed.\n2. Histologically proven, metastatic or advanced epithelial cancer including the following cancer types:\n\n   1. Urothelial\n   2. Cervical\n   3. Ovarian epithelial\n   4. Triple-negative breast\n   5. HR+\u002FHER2- breast\n   6. Pancreatic ductal adenocarcinoma\n   7. Gastric adenocarcinoma\n   8. Esophageal carcinoma\n   9. Non-small cell lung\n   10. Colorectal\n3. Progressive disease at baseline, refractory or relapsed to standard of care or who have declined standard therapy.\n4. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.\n6. Life expectancy of \\> 12 weeks.\n7. Echocardiogram (ECHO) or multiple gated acquisition scan showing an ejection fraction greater than or equal to 50%.\n8. Electrocardiogram (ECG) showing no clinically significant abnormality at Screening or showing an average QTc interval \\\u003C 450 msec in males and \\\u003C 470 msec in females (\\\u003C 480 msec for participants with bundle branch block). Either Fridericia's or Bazett's formula may be used to correct the QT interval.\n9. Oxygen saturation of greater than or equal to 90% on room air measured by pulse oximetry.\n10. Adequate organ function as defined by laboratory values at Screening.\n11. Willing and able to provide written informed consent.\n12. Willing to perform and comply with all study procedures including undergoing study-related biopsies and attending clinic visits as scheduled.\n13. Men must abstain from sperm donation during study treatment or for 4 months following last dose of study treatment.\n14. Men and WOCBP must be willing to practice a highly effective method of contraception.\n\nExclusion Criteria:\n\n1. Known active CNS metastasis and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression for at least 4 weeks by repeat imaging), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study intervention.\n2. Pregnant or nursing women.\n3. Must be \\> 28 days beyond major surgery, including hepatectomy or joint replacement.\n4. Prior allogeneic bone marrow transplantation or solid organ transplant.\n5. Spinal cord compression not definitively treated with surgery and\u002For radiation.\n6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n7. Any acute illness including fever (\\> 100.4° F or \\> 38° C) within 7 days prior to Day 1\n8. Active systemic bacterial, fungal, or viral infection within 7 days prior to Day 1. Participant cannot have tested positive for COVID-19 within 7 days prior to Day 1.\n9. Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV).\n10. Other primary malignancies, except:\n\n    1. Adequately treated basal cell or squamous cell carcinoma\n    2. In situ carcinoma of the cervix or bladder, treated curatively and without evidence of recurrence for at least 2 years prior to the study, or\n    3. A primary malignancy which has been completely resected and in complete remission for at least 2 years\n11. History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n12. Prior grade \\> 3 immune-related AEs such as pneumonitis, colitis, hepatitis, nephritis; prior dermatitis and endocrinopathies are allowed provided corticosteroids are no longer required and endocrine-replacement therapy is stable and discontinued from prior therapy.\n13. Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.\n14. History of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious active arrhythmias or other clinically significant cardiac disease within 12 months of enrollment.\n15. Toxicity from previous anti-cancer therapy defined as toxicities (other than alopecia, or laboratory values listed above) not yet resolved to NCI CTCAE v5.0 Grade ≤ 1 or baseline. Participants with chronic Grade 2 toxicities (eg, peripheral neuropathy, laboratory values) may be eligible per the discretion of the Investigator and Medical Monitor.\n16. Has received:\n\n    1. Radiotherapy within 2 weeks of first administration of MT-302\n    2. Cytotoxic chemotherapy for treatment of the primary malignancy within 28 days or 5 half-lives, whichever is shorter, of administration of MT-302\n    3. Immune therapy for primary malignancy (eg, monoclonal antibody therapy, checkpoint inhibitors) within 28 days or 5 half-lives, whichever is shorter of first administration of MT-302\n    4. Targeted therapies for primary malignancy within 28 days or 5 half-lives, whichever is shorter, of first administration of MT-302\n    5. Anti-cancer vaccine within 12 weeks of first administration of MT-302\n    6. COVID-19 mRNA vaccine within 6 weeks of first administration of MT-302\n17. Has received a live vaccine ≤ 6 weeks prior to first administration of MT-302\n18. Has received packed red blood cells or platelet transfusion within 2 weeks prior to first administration of MT-302\n19. History of an allergic reaction to any of the excipients\n20. Enrollment in another interventional clinical trial within 28 days or 5 half-lives of the drug, whichever is shorter, of first administration of MT-302\n21. Any other condition that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the study requirements.",{"count":91,"type":20},48,[23],"MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.",[95],"Epithelial Tumors, Malignant",[97,98,99,100,101,102,36,103,38,104,105,106,107,108,109,29,30,31],"Urothelial cancer","Cervical cancer","Ovarian epithelial","Triple-negative breast cancer","HR+\u002FHER2- breast cancer","Pancreatic ductal adenocarcinoma","Esophageal carcinoma","Colorectal cancer","TROP-2 expressing tumors","MT-302","Anti-TROP-2 chimeric antigen receptor","Myeloid cells","Monocytes","2024-01-16",{"date":112,"type":45},"2024-01-18",{"date":114,"type":45},"2023-08-02",{"date":116,"type":20},"2028-08-31",{"name":51,"class":52},6,""]