[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-tumor-net\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-tumor-net":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":25,"conditions":26,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100588601","phase-1-a-study-of-mt-4561-in-patients-with-various-advanced-solid-tumors-100588601",false,"NCT06943521","A Study of MT-4561 in Patients With Various Advanced Solid Tumors","A Phase I\u002FII, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam","Main Inclusion Criteria:\n\nPatients who have failed at least 1 prior therapy and, who have no standard treatment options demonstrated to provide clinical benefit or who are intolerable to or refuse further standard therapies will be enrolled.\n\n* Male or female patient aged 18 years or older at the time of signing the informed consent form\n* ≥ 1 measurable lesion by the RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1\n* Life expectancy of at least 3 months\n* Adequate bone marrow function\n* Adequate hepatic function\n* Adequate renal function estimated creatinine clearance ≥ 60 mL\u002Fmin calculated using the Cockcroft and Gault equation or by institutional method\n* Part 1: Patients must have a confirmed histologic or cytologic diagnosis of one of the following solid tumors for participation in the study: head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), esophageal cancer, gastric cancer, biliary tract cancer, pancreatic ductal adenocarcinoma (PDAC), breast cancer, ovarian cancer, cervical cancer, endometrial cancer, prostate cancer, urothelial carcinoma, neuroendocrine tumor (NET) or neuroendocrine carcinoma (NEC), soft tissue sarcoma, and NUT carcinoma.\n\nMain Exclusion Criteria:\n\n* Patients with active brain or leptomeningeal metastases\n* Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for alopecia\n* Prior systemic anticancer therapy within 4 weeks before first dose of investigational medicinal product (IMP) or 5 half-lives, whichever is shorter, and prior radiotherapy within 2 weeks before first dose of IMP\n* History of congenital long QT syndrome or clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation or Torsades de pointes)\n* Patients who received drugs with a known risk of QT interval prolongation or Torsades de pointes within 14 days or 5 half-lives, whichever is shorter, before the start of IMP administration\n* QT interval corrected for heart rate using Fridericia's correction (QTcF) \\> 470 msec at screening","ALL","18 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a First In Human (FIH), multicenter, open-label, Phase I\u002FII study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts.\n\nPart 1 is aimed at evaluating safety, tolerability, PK and pharmacodynamics of MT-4561 and determining the Maximum Tolerated Dose (MTD) using the Bayesian Optimal Interval (BOIN) design.\n\nThe study details and doses of Part 2 (dose-optimization) and Part 3 (Drug-Drug Interaction) will be available after review of applicable Part 1 results.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Head and Neck Squamous Cell Carcinoma (HNSCC)","Non-small Cell Lung Cancer (NSCLC)","Esophageal Cancer","Gastric Cancer","Biliary Tract Cancer","Pancreatic Ductal Adenocarcinoma (PDAC)","Breast Cancer","Ovarian Cancer","Cervical Cancer","Endometrial Cancer","Prostate Cancer","Urothelial Carcinoma","Neuroendocrine Tumor (NET)","Neuroendocrine Carcinoma (NEC)","Soft Tissue Sarcoma","Nuclear Protein in Testis (NUT) Carcinoma","RECRUITING","2025-12-04",{"date":46,"type":47},"2025-12-11","ACTUAL",{"date":49,"type":47},"2025-04-18",{"date":51,"type":20},"2028-08",{"name":53,"class":54},"Tanabe Pharma America, Inc.","INDUSTRY",6,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100594039","therapeutic-study-of-177lu-ctr-fapi-in-advanced-metastatic-digestive-malignancies-100594039","NCT07014254","Therapeutic Study of 177Lu-CTR-FAPI in Advanced Metastatic Digestive Malignancies","Therapeutic Study of 177Lu-CTR-FAPI-targeted Nuclear Drugs in Advanced Metastatic Digestive Malignancies","Inclusion Criteria:\n\n* 1\\. voluntary participation in this study and signing of informed consent;\n* 2\\. age 18-75 years (both 18 and 75 years);\n* 3\\. ECOG (Eastern Cooperative Oncology Group) physical status score: 0-1;\n* 4.Advanced metastatic gastrointestinal malignancies with high FAP expression: e.g. neuroendocrine tumours (NET G2, G3), neuroendocrine carcinomas (NEC), pancreatic ductal adenocarcinomas (PDAC), gastric adenocarcinomas, colorectal carcinomas, intrahepatic cholangiocarcinomas (ICC), and squamous carcinomas of the oesophagus. All of the above should be confirmed by 68Ga-FAPI PET\u002FCT with high FAP expression (criterion: more than 50% of lesions with SUVmax ≥10). 5.\n* 5\\. Disease status: locally advanced unresectable or metastatic lesions confirmed by imaging (CT\u002FMRI\u002FPET-CT); at least 1 measurable lesion (RECIST 1.1 criteria).\n* 6\\. good major organ function, i.e. the following criteria are met (no blood components, cell growth factors are allowed within 14 days prior to the first dose)\n\n  1. Creatinine clearance ≥ 50 ml\u002Fmin (calculated according to the Cockcroft-Gault formula) or serum creatinine ≤ 150 μmol\u002FL;\n  2. Urine protein \\\u003C2+; if urine protein ≥2+, then 24-hour urine protein quantification must show \\\u003C2 g of protein;\n  3. White blood cell count ≥ 2 × 109\u002FL;\n  4. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n  5. Platelets ≥ 75 × 109\u002FL;\n  6. Haemoglobin ≥ 8.0 g\u002FdL;\n  7. Serum albumin ≥ 30 g\u002FL.\n  8. Total bilirubin ≤ 3 × ULN;\n* 7\\. Women of childbearing age who undergo a blood pregnancy test within 72 h prior to treatment need to be excluded from pregnancy and must be non-lactating and willing to use a highly effective method of contraception for the duration of the trial and for 6 months after completion of treatment. For men, agreement to use a highly effective method of contraception or to have been surgically sterilised during the study and for 4 months after the end of treatment.\n\nExclusion Criteria:\n\n* 1\\. Disease-related:\n\n  1. Combination of other malignancies (except non-melanoma skin cancer or radical tumours without recurrence within 5 years);\n  2. Presence of central nervous system metastases or carcinomatous meningitis;\n  3. Uncontrolled cancer pain (requiring long-term high-dose opioids) or cachexia (≥20% weight loss in 6 months);\n  4. Diabetes mellitus (fasting blood glucose \\> 2 x ULN) that is not well controlled with optimal medical supportive therapy;\n  5. Accompanied by poorly controlled plasmapheresis, including pleural fluid, ascites, and pericardial effusion; controlled with treatment and stable (asymptomatic, not requiring interventional therapy, and stable on imaging) for ≥2 weeks may be included;\n  6. Severe urinary incontinence, hydronephrosis, severe voiding dysfunction or the need for an indwelling urinary catheter for any reason;\n  7. Subjects with uncontrolled cardiac clinical symptoms or disease, including but not limited to: i) NYHA class 2 or higher heart failure; ii) unstable angina; iii) myocardial infarction within 1 year prior to enrolment; iv) left ventricular ejection fraction (LVEF) \\\u003C50%; v) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n  8. Co-occurring active hepatitis B (HBV-DNA testing is required for HBsAg-positive individuals with HBV DNA ≥500 IU\u002FmL or 2500 copies\u002FmL), and hepatitis C (HCV-Ab-positive and above the lower limit of detection of the analytical method);\n  9. Persons known to have acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) testing positive. Persons with active syphilis infection.\n* 2\\. Treatment related\n\n  1. Radiotherapy within 4 weeks or previous radiotherapy to \\>25% of the bone marrow area;\n  2. Received systemic anti-tumour therapy such as chemotherapy, immunotherapy, targeted therapy within 4 weeks;\n  3. Treatment with surgery (biopsy puncture, non-anti-tumour surgical operations such as ERCP may be excluded), radiofrequency ablation or cryoablation, interferon, transcatheter arterial embolisation (TAE) or transcatheter arterial chemoembolisation (TACE) within 12 weeks;\n  4. Prior FAP-targeted therapy (e.g., FAPI-PRRT, anti-FAP antibody drugs);\n  5. Presence of contraindications to radionuclide therapy (e.g., myelodysplastic syndrome, extensive bone metastases with bone marrow failure).\n\n     Comorbidities and Risks:\n  6. Previous antineoplastic therapy resulting in toxicity that has not recovered to grade ≤1 according to the NCI-CTCAE v5.0 classification (with the exception of lowered lymphocyte counts, alopecia, and the indicators mentioned in the inclusion criteria, and with the exception of partially tolerable chronic grade 2 toxicity, in the judgement of the investigator).\n* 3\\. Other exclusions\n\n  1. History of allergy to peptide radiopharmaceuticals;\n  2. Inability to co-operate with long-term follow-up (e.g., mental illness, geographical constraints, etc.);\n  3. Refusal of contraception by pregnant or lactating women or patients of childbearing age.","80 Years",{"count":65,"type":20},20,[67],"NA","This was a single-centre, single-arm, non-blinded, prospective study using 20 patients with advanced metastatic GI malignancies recruited to treat patients with advanced metastatic GI malignancies with 177Lu-CTR-FAPI to assess the safety of 177Lu-CTR-FAPI in advanced metastatic GI malignancies; this included radiation therapy dosimetry and initial treatment Determination of Effectiveness",[32,70,71,39],"Adenocarcinoma of the Stomach","Colorectal Cancer Metastatic",[73],"177Lu-CTR-FAPI","NOT_YET_RECRUITING","2025-06-08",{"date":77,"type":47},"2025-06-10",{"date":79,"type":20},"2025-06-20",{"date":81,"type":20},"2028-04-30",{"name":83,"class":84},"Xijing Hospital","OTHER",1]