[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chengdu New Radiomedicine Technology Co. LTD.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100537486","phase-1-safety-and-efficacy-of-nrt6008-in-patients-with-unresectable-locally-advanced-pancreatic-cancer-lapc-and-advanced-pancreatic-cancer-with-lymph-node-metastases-100537486",false,"NCT06278454","Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases","A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases","Inclusion Criteria:\n\n1. Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;\n2. Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;\n3. Evaluated as unresectable LAPC or metastatic pancreatic cancer with lymph node metastasis only, as determined by the investigator; or having contraindications to surgery, or refusing surgical resection;\n4. ECOG performance status score ≤1;\n5. Expected survival ≥3 months;\n6. According to RECIST v1.1 criteria, there is only one measurable lesion in the pancreas confirmed by imaging, and the lesion has the shortest axis diameter ≥2.0 cm, the longest axis diameter ≤6.0 cm (based on baseline imaging);\n7. Adequate normal organ and marrow function as defined below: (1) Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated by the Cockcroft-Gault formula); (2) Liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN; serum total bilirubin ≤1.5×ULN; (3) Bone marrow function \\[\\[no blood transfusion or granulocyte colony-stimulating factor (G-CSF), human thrombopoietin (TPO), or TPO receptor agonist treatment within 14 days prior to signing informed consent\\]: neutrophils ≥1.5×10\\^9\u002FL, hemoglobin ≥90 g\u002FL, platelets ≥100×10\\^9\u002FL; (4) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n8. Female and male participants of reproductive age must voluntarily agree to practice strict and effective contraception after signing the informed consent form, during the study period, and within 12 months after administration of the investigational drug. Males are prohibited from donating sperm during this period. Female participants of reproductive age must have a negative pregnancy test result during the screening period and within 24 hours before administration of the investigational drug.\n\nExclusion Criteria:\n\n1. Allergic to the investigational drug NRT6008 injection itself or any of its components;\n2. Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;\n3. Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for discontinuation of traditional chinese medicine or herbal medicine for at least 7 days prior to the screening period;\n4. Contraindications to anesthesia;\n5. History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin cancer, cervical carcinoma in situ, or basal cell carcinoma of the skin, Stage I Grade 1 endometrial carcinoma, or thyroid cancer;\n6. Presence or suspected presence of distant metastases according to imaging;\n7. Pregnant or lactating females;\n8. Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;\n9. Evidence of radiographic invasion into stomach, duodenum or peritoneum;\n10. Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;\n11. Within 6 months prior to the the first administration of chemotherapy, occurrence of acute pancreatitis, severe gastrointestinal bleeding, severe cardiovascular diseases (including but not limited to stroke, unstable angina), or occurrence of acute infections requiring systemic treatment within 2 weeks before the screening period;\n12. Participated in other interventional clinical trials within 1 month prior to the first administration of chemotherapy;\n13. Positive for human immunodeficiency virus (HIV) antibodies;\n14. Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb), HBV DNA testing required, participants with HBV-DNA levels below the lower limit of the reference range or \\\u003C 500 IU\u002FmL will be eligible for inclusion in this study (use of antiviral drugs during the study period is required);\n15. Positive for hepatitis C virus (HCV) antibodies, HCV RNA testing required, participants with negative HCV RNA results will be eligible for inclusion in this study;\n16. Participants with syphilis infection or active tuberculosis;\n17. Other reasons deemed unsuitable for participation in this trial by the investigators.","ALL","18 Years","80 Years",{"count":20,"type":21},58,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.",[27,28,29],"Unresectable Pancreatic Cancer","Advanced Pancreatic Cancer","Lymph Node Metastases",[31,32,33,34],"Yttrium-90","Endoscopic ultrasound-guided fine-needle injection","Locally Advanced Pancreatic Carcinoma","Advanced Pancreatic Cancer with Lymph Node Metastases","RECRUITING","2026-06-08",{"date":38,"type":39},"2026-06-10","ACTUAL",{"date":41,"type":39},"2024-01-09",{"date":43,"type":21},"2028-06",{"name":45,"class":46},"Chengdu New Radiomedicine Technology Co. LTD.","INDUSTRY",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100586139","phase-1-safety-trial-of-68ga177lu-nrt6020-in-fap-positive-advanced-solid-tumor-patients-100586139","NCT06911489","Safety Trial of 68Ga\u002F177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients","A Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of 68Ga-NRT6020 Injection and 177Lu-NRT6020 Injection in FAP-Positive Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female participants aged 18-80;\n2. Histologically or cytologically confirmed advanced solid tumors; advanced solid tumors patients who have failed prior standard therapies or deemed unsuitable for standard therapies (only for stage 2 and stage 3);\n3. Have at least one measurable lesion as per RECIST v1.1\u002FPERCIST criteria;\n4. For stage 2 and stage 3, a positive 68Ga-NRT6020 Injection PET\u002FCT imaging results is required;\n5. Participants must have adequate organ function;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Life expectancy ≥3 months;\n8. For women of childbearing potential, a negative blood pregnancy test within 3 days before the first dose is required, and fertile male and female participants of childbearing potential must agree to use effective contraception with their partners from the signing of the informed consent form until 12 months after the last dose of the investigational drug.\n\nKey Exclusion Criteria:\n\n1. Known allergy to 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection, or any of their ingredients, such as alcohol;\n2. Presence or suspicion of primary central nervous system tumors or intracranial metastasis;\n3. For stage 1: Received prior antitumor treatments within 7 days before the investigational drug dosing, and\u002For plan to receive antitumor treatments during the safety observation period; For stage 2 and stage 3: Received prior antitumor treatments within 4 weeks before the initial investigational drug dosing, including chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc.;\n4. History of other malignancies within 5 years prior to the first dose of the investigational drug, excluding cured non-melanoma skin cancer, early-stage papillary thyroid cancer, and cervical carcinoma in situ;\n5. Presence of severe or uncontrolled cardiac diseases requiring treatment;\n6. High risk of bleeding;\n7. Active syphilis or human immunodeficiency virus (HIV) antibody positive;\n8. HBsAg-positive or HBcAb-positive with HBV-DNA levels above the detection limit;\n9. Failure to alleviate previous antitumor treatment toxicities to Grade 0 or 1 according to CTCAE v5.0;\n10. Participate in any other clinical trials within 1 month before the first dosing of 68Ga-NRT6020 Injection.",{"count":56,"type":21},132,[24],"Stage 1 (Safety study for 68Ga-NRT6020 Injection):\n\nThe goal of this clinical trial stage is to evaluate the safety of 68Ga-NRT6020 Injection in participants with advanced solid tumors. The study will also assess the biodistribution, radiation dosimetry, imaging profile, and pharmacokinetics of the drug. Additionally, researchers aim to investigate how consistent the PET\u002FCT imaging results of 68Ga-NRT6020 are with 18F-FDG PET\u002FCT imaging and FAP immunohistochemistry (IHC) results.\n\nStage 2 (Safety and tolerability study for 177Lu-NRT6020 Injection):\n\nThis stage focuses on evaluating the safety and tolerability of 177Lu-NRT6020 Injection in FAP-positive participants with advanced solid tumors. Researchers will also assess the safety of 68Ga-NRT6020 Injection in this population. The study will evaluate the biodistribution, radiation dosimetry, pharmacokinetics, and preliminary efficacy of 177Lu-NRT6020 Injection. Additionally, the imaging profile of 68Ga-NRT6020 and its consistency with other imaging techniques will be further investigated.\n\nStage 3 (Preliminary efficacy study for 68Ga\u002F177Lu-NRT6020 Injection):\n\nThe objective of this stage is to evaluate the safety of 177Lu-NRT6020 Injection and 68Ga-NRT6020 Injection in FAP-positive participants with advanced solid tumors, as well as to determine the recommended phase 2 dose (RP2D) of 177Lu-NRT6020 Injection. The study will also assess the preliminary efficacy, biodistribution, radiation dosimetry, and pharmacokinetics of the drugs. Furthermore, researchers will investigate the imaging profile of 68Ga-NRT6020 and its consistency with other imaging techniques.",[60],"Solid Tumor Malignancy",[62,63,64,65],"solid tumor","Radionuclide Drug Conjugates","Companion Diagnostics","FAP","2026-01-29",{"date":68,"type":39},"2026-02-02",{"date":70,"type":39},"2025-11-29",{"date":72,"type":21},"2027-12",{"name":45,"class":46},""]