[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100497077","phase-1-study-to-determine-the-safety-and-pharmacokinetics-of-do-2-in-patients-with-advanced-or-refractory-solid-tumours-100497077",false,"NCT05752552","Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours","A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET Kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours","Inclusion Criteria:\n\n* 18 years or older\n* histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, no longer eligible for approved, available standard therapies. To be entered patients must have proven MET exon 14 skipping mutation, determined by local next generation sequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, from an assessment not older than 3 months\n* measurable disease in accordance with RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* adequate bone marrow function, without the support of cytokines\n* adequate liver function\n* adequate renal function with serum creatinine \\\u003C1 x institutional UNL and GFR within normal range\n* agree to follow the contraception requirements of the trial\n* signed informed consent, indicating study patients understand the purpose of and procedures required for the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n* tumour harbouring other known oncogenic mutations promoting tumour growth\n* major surgery within 3 weeks before enrolment\n* chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy, or any other study drug within 3 weeks before study drug administration\n* antibody based cancer therapy within 4 weeks before administration of the first dose of DO-2\n* patients who became progressive on previous treatment with a MET-kinase inhibitor\n* patients with brain metastases are excluded unless all of the following criteria are met:\n\n  1. CNS lesions are asymptomatic and previously treated\n  2. No ongoing requirement for corticosteroids as therapy for CNS metastases\n  3. Imaging demonstrates stability of disease \\> 28 days from last treatment for CNS metastases\n* leptomeningeal involvement (leptomeningeal carcinomatosis)\n* history of uncontrolled heart disease including unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, clinically significant rhythm or conduction abnormality, congenital long QT syndrome, obligate use of a cardiac pacemaker, QTc at screening greater than 450 milliseconds in males and greater than 470 milliseconds in females\n* uncontrolled arterial hypertension despite appropriate therapy\n* positive pregnancy test (urinary beta-hCG) at screening (applicable to women of child-bearing potential who are sexually active)\n* mental status alteration or history of major psychiatric illness, which may potentially impair patient's compliance with study procedures\n* signs and symptoms of active infection requiring systemic therapy\n* other medical condition (e.g. pre-existing kidney dysfunction) that in the opinion of the investigator makes it undesirable for a patient to participate\n* inability or unwillingness to swallow capsules and malabsorption syndrome or other condition that would interfere with enteral absorption","ALL","18 Years",{"count":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is a first-in-human, open-label, 2-part, Phase 1 dose escalation study of DO-2, administered orally to patients with advanced or refractory solid tumours, with MET aberrations, and no available, approved therapeutic alternative. The dose escalation is completed, Part 2 of the study is ongoing.",[26,27,28,29,30,31,32],"Adult Solid Tumor","Advanced Solid Tumor","Refractory Tumor","Non-small Cell Lung Cancer","Non-small Cell Carcinoma","Lung Cancer","Hereditary Renal Papillary Cancer","RECRUITING","2026-03-30",{"date":36,"type":37},"2026-04-03","ACTUAL",{"date":39,"type":37},"2022-12-20",{"date":41,"type":20},"2028-09",{"name":43,"class":44},"DeuterOncology","INDUSTRY",13,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100551134","phase-1-trametinib-plus-anlotinib-combined-with-tislelizumab-in-kras-mutant-nsclc-100551134","NCT06456138","Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC","Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant Advanced Non-small Cell Lung Cancer Patients: a Multi-center, Open-label, Phase 1\u002F2 Study","Inclusion Criteria:\n\n1. According to the 8th edition of the AJCC\u002FUICC TNM staging system for NSCLC, patients with locally advanced (stage III B\u002FIII C), metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology who are unable to undergo surgery and radical concomitant radiochemotherapy and are confirmed to have at least one measurable lesion according to RECIST 1.1.\n2. KRAS mutation positive detected by ARMS or NGS;\n3. Have been treated with 1st line of standard therapy and experienced disease progression;\n4. Patients who were assessed as CR, PR, or SD (reduction) after being treated with 2 cycles of anlotinib and trametinib.\n5. No active brain metastases;\n6. Age ≥18 years and ≤75 years;\n7. ECOG PS score: 0 to 2;\n8. Palliative radiotherapy must be completed 7 days before the first dose of study drug is administered;\n9. The main organs function is normal, that is, the following criteria met:\n10. Good hematopoietic function, defined as absolute neutrophil count ≥1.5×10\\^9 \u002FL, platelet count≥100 ×10\\^9 \u002FL, hemoglobin ≥90g\u002FL \\[no blood transfusion or no erythropoietin (EPO) dependence within 7 days before enrollment\\]\n11. Biochemical test results should meet the following criteria: BIL \\\u003C 1.25 times the upper limit of normal value (ULN); ALT and AST \\\u003C 2.5 × ULN; in case of liver metastases, ALT and AST \\\u003C 5 × ULN; Cr ≤1.5×ULN or creatinine clearance (CCr) ≥60ml\u002Fmin; Coagulation function is good, INR and PT ≤1.5 times ULN; if the subject is receiving anticoagulant treatment, PT should be within the prescribed range of use of anticoagulant drugs;\n12. Women of child-bearing age should agree to take contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study and within 6 months after the study; non-breast-feeding patients whose serum or urinary pregnancy test should be negative; male patients should agree to take contraceptive measures during the study and within 6 months after the study.\n13. Patients are voluntarily enrolled into the study, sign the informed consent form and have good compliance.\n\nExclusion Criteria:\n\n1. Small cell lung cancer (including mixed small cell and non-small cell lung cancer);\n2. Patients who have received previous treatment ≥ 4th lines of standard therapies.;\n3. There are obvious bleeding symptoms or active autoimmune disease;\n4. Patients with other driver mutation.\n5. Patients with many factors affecting oral medication, such as dysphagia, gastrointestinal resection, chronic diarrhea and intestinal obstruction;\n6. Patients who are known to have active brain metastases, spinal cord compression, carcinomatous meningitis, or brain or leptomeningeal disease diagnosed by CT or MRI at the time of screening;\n7. Patients with severe and \u002F or uncontrolled diseases, such as:\n8. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg);\n9. Active or uncontrolled serious infection;\n10. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n11. Not completely controlled eye inflammation or eye infection, or any condition that may lead to the above-mentioned ocular diseases\n12. Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n13. Routine urine test result indicates that urine protein ≥++, and 24-hour urine protein quantitation is confirmed to be \\> 1.0 g;\n14. Active tuberculosis, etc.;\n15. Uncontrolled hypercalcemia (\\> 1.5 mmol\u002FL calcium ion or calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN), or symptomatic hypercalcemia requiring continued diphosphate therapy;\n16. Long-term unhealed wounds or fractures;\n17. Patients who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders;\n18. Patients who are known to have severe allergies (≥ grade 3) to active ingredients and any excipients of study drugs;\n19. Patients who have other malignant tumors (except radical cervical carcinoma in situ, non-melanoma skin cancer, etc.) at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients completing the study.\n20. The subjects or their sexual partners cannot or refuse to take effective contraceptive measures during the clinical trial.\n21. Pregnant or breast-feeding women.\n22. Patients who are allergic to any medicine or any ingredient; the patients with a history of treatments involving MEK inhibitors (trametinib, selumetinib, etc.) and RTKs inhibitors (anlotinib, sorafenib, apatinib, cabozantinib, etc.) were considered ineligible.\n23. Patients in other situations who are evaluated by the investigator to be ineligible to be enrolled.","75 Years",{"count":55,"type":20},60,[23,57],"PHASE2","Lung cancer is the most common cause of cancer-related death worldwide. Approximately 85% to 90% of lung cancer cases are non-small cell lung cancer (NSCLC), of which KRAS is one of the most common driver genes, occurring in 25-30% of lung adenocarcinomas and 3-5% of squamous cell carcinomas. KRAS-mutant NSCLC had been considered undruggable in past decades. This research sought to address a significant challenge in treating NSCLC with KRAS mutations, which are notoriously difficult to target effectively. Here, we proposal that the combined use of anlotinib and trametinib combined with tislelizumab may form an effective strategy for the treatment of KRAS-mutant NSCLC patients.",[60,61,28],"KRAS Mutation-Related Tumors","Advanced Lung Cancer",[63,64,65,66],"KRAS-mutant NSCLC","Trametinib","Anlotinib","Tislelizumab","NOT_YET_RECRUITING","2024-06-10",{"date":70,"type":37},"2024-06-13",{"date":72,"type":20},"2024-07-01",{"date":74,"type":20},"2028-12-31",{"name":76,"class":77},"Shanghai Chest Hospital","OTHER",1]