[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumors-phase-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumors-phase-1":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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},"100612923","phase-1-safety-and-tolerability-evaluation-of-cel001-injection-in-advanced-solid-tumors-100612923",false,"NCT07259889","Safety and Tolerability Evaluation of CEL001 Injection in Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety and Tolerability of CEL001 Injection in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to enter this study:\n\n  1. Age ≥ 18 years old, gender not limited;\n  2. ECOG physical fitness status score: 0-1 points;\n  3. Subjects with advanced or metastatic tumors diagnosed by histology or cytology, who have failed\\* or unable to tolerate standard treatment according to CSCO guidelines or NCCN guidelines, or lack effective treatment methods;\n  4. Male subjects should weigh no less than 50 kilograms, and female subjects should weigh no less than 45 kilograms;\n  5. Expected survival time exceeds 3 months;\n  6. There must be at least one measurable lesion, defined as measurable according to the RECIST 1.1 standard;\n  7. Prior to treatment, the main organ function meets the following criteria (no blood transfusion, long-acting EPO, or long-acting G-CSF treatment received within 14 days prior to the administration of the investigational drug, which can be reduced to 7 days for short acting EPO or G-CSF):\n\n  \u003C!-- -->\n\n  1. Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 90 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL or ≥ 5.6 mmol\u002FL;\n  2. Kidney: serum creatinine ≤ 1.5 x upper limit of normal range (ULN) or Ccr ≥ 50 mL\u002Fmin (estimated according to the Cockcroft Gault formula);\n  3. Liver: Total bilirubin ≤ 1.5 × ULN (including liver metastasis or liver cancer subjects), AST and ALT ≤ 2.5 × ULN (including liver metastasis or liver cancer subjects ≤ 5 × ULN);\n  4. Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN, Partially Activated Thromboplastin Time (APTT) ≤ 1.5 × ULN; 8. Women should agree to take appropriate contraceptive measures (such as intrauterine devices \\[IUDs\\], birth control pills, or condoms) during the study period and within 6 months after the end of the study. They must have a negative serum pregnancy test within 7 days prior to enrollment in the study and must be non lactating subjects; Men should agree to take appropriate contraceptive measures during the study period and within 6 months after the end of the study.\n\n     * Standard treatment failure:\n\n       * Non small cell lung cancer: (1) Subjects with metastatic non driver gene mutations: disease progression or recurrence after at least second-line treatment (including platinum based chemotherapy); (2) Subjects with driver gene mutations such as EGFR, ROS1, ALK in tumors should have received targeted therapy for these mutations that failed, followed by at least second-line treatment (including platinum based chemotherapy) for disease progression or recurrence;\n       * Small cell lung cancer: disease progression or recurrence after receiving at least second-line treatment in the past;\n       * Colorectal cancer: disease progression or recurrence after at least second-line treatment in the past (standard chemotherapy regimens include fluorouracil or its derivatives, oxaliplatin, and irinotecan, Subjects with BRAF V600E mutation have used BRAF inhibitors, and subjects with MSI-H\u002FdMMR need to have used PD-1\u002FPD-L1 treatment);\n       * Head and neck squamous cell carcinoma: disease progression or recurrence after receiving at least second-line treatment (including platinum based chemotherapy) in the past;\n       * Urethral epithelial cancer: disease progression or recurrence after receiving at least second-line treatment in the past (recommended treatment regimens in guidelines include PD-1\u002FPD-L1 therapy, platinum based chemotherapy regimen, paclitaxel based chemotherapy regimen, vediximab, and vinblastine, and subjects with FGFR2\u002F3 mutations have already used edatinib);\n       * Esophageal cancer: disease progression or recurrence after receiving at least second-line treatment (including platinum based chemotherapy) in the past;\n       * Cervical cancer: disease progression or recurrence after receiving at least second-line treatment in the past (including platinum based chemotherapy, subjects who meet PD-L1 positive or TMB-H or MSI-H\u002FdMMR criteria must have received PD-1\u002FPD-L1 treatment);\n       * Hepatocellular carcinoma: disease progression or recurrence after receiving at least second-line treatment in the past;\n       * Renal cell carcinoma: disease progression or recurrence after receiving at least second-line treatment in the past;\n       * For other unspecified malignant tumors, refer to the latest guidelines of CSCO or NCCN.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will not be eligible to enter this study:\n\n  1. Individuals allergic to any component of CEL001 injection, including those allergic to penicillin;\n  2. Have received anti-tumor treatments such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or participated in other clinical trials within 4 weeks or 5 known drug half lives (whichever is shorter) before the first use of the investigational drug;\n  3. Have received traditional Chinese medicine or modern Chinese medicine preparations with anti-tumor indications in the instructions within 14 days before the first administration;\n  4. Within the past 5 years, have had malignant tumors other than those treated in this study (excluding cured thyroid cancer, basal cell carcinoma of the skin, and cervical carcinoma in situ);\n  5. The adverse reactions of previous anti-tumor treatments have not yet recovered to NCI CTCAE v5.0 grade evaluation ≤ 1 (excluding toxicity judged by researchers to have no safety risks such as hair loss);\n  6. Have undergone surgical procedures within 4 weeks prior to receiving treatment or have not fully recovered from any previous invasive procedures;\n  7. If there are clinical symptoms of central nervous system metastasis or meningeal metastasis, or if there is other evidence indicating that the participant's central nervous system metastasis or meningeal metastasis has not been controlled, the researcher determines that it is not suitable for inclusion;\n  8. Individuals with active infection (NCI CTCAE v5.0 ≥ 2) or any other suspected infection risk assessed by researchers;\n  9. Have a history of autoimmune diseases, immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n  10. Subjects with active hepatitis B or active hepatitis C;\n  11. Individuals who have previously received immunotherapy;\n  12. Have a history of serious cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities (requiring clinical intervention for ventricular arrhythmias, grade II-III atrioventricular block, etc.), myocardial infarction, history of coronary artery bypass surgery, heart failure, New York Heart Association (NYHA) classification of grade II or above, left ventricular ejection fraction (LVEF) ≤ 50% and thrombotic findings, male QTcF\\>450msec or female QTcF\\>470msec, etc; Subjects with a history of severe cerebrovascular disease such as stroke;\n  13. It is necessary to combine other anti-tumor treatments (including various radiotherapy, chemotherapy, immunotherapy, targeted therapy, traditional Chinese medicine treatment, etc.);\n  14. Have a clear history of neurological or mental disorders, including epilepsy or dementia;\n  15. The researchers believe that there are other reasons why the subjects are not suitable to participate in this clinical study.","ALL","18 Years",{"count":19,"type":20},13,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is the first human, open label, dose escalation, and expansion phase I clinical trial aimed at evaluating the safety, tolerability, preliminary efficacy, pharmacokinetic characteristics, biomarker changes, and immunogenicity of CEL001 injection in the treatment of advanced solid tumors.",[26],"Advanced Solid Tumors (Phase 1)","RECRUITING","2025-11-27",{"date":30,"type":31},"2025-12-02","ACTUAL",{"date":33,"type":31},"2025-06-16",{"date":35,"type":20},"2028-06-15",{"name":37,"class":38},"Guangzhou Xiling Biotechnology Co., Ltd.","INDUSTRY",1,{"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":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100573912","phase-1-a-phase-i-study-oflnf2007-monotherapy-in-patients-with-advanced-solid-tumors-100573912","NCT06752447","A Phase I Study OfLNF2007 Monotherapy in Patients with Advanced Solid Tumors","A Phase I Clinical Study of Safety, Tolerability, Pharmacokinetic\u002Fpharmacodynamic Characteristics and Initial Efficacy of LNF2007 Monotherapy in Patients with Advanced Solid Tumors","Inclusion Criteria:\n\n* Study participants must meet all of the following inclusion criteria to be enrolled in the study:\n\n  1. Age ≥18 years old, gender unlimited;\n  2. United States Eastern Oncology Consortium (ECOG) physical strength score 0-1;\n  3. Expected survival ≥12 weeks;\n  4. Patients with advanced solid tumors confirmed histologically or cytologically (gastric cancer, pancreatic cancer, and cholangiocarcinoma are preferred) who have failed after adequate standard treatment, or who lack standard treatment options (standard treatment is defined as the standard treatment guidelines that have been agreed in the country (if applicable) or the standard treatment status in the country); Standard treatment failure is defined as disease progression or tumor recurrence or metastasis during or after treatment, or intolerance);\n  5. Agree to provide archived tumor tissue specimens or fresh tissue specimens within 2 years of the primary or metastatic lesion (to explore the characteristics of biomarkers in tumor tissue); If the subject is unable to provide a tumor tissue sample, the participant can be enrolled after evaluation by the investigator, provided that other inclusion criteria are met.\n  6. There is at least one evaluable tumor lesion according to RECIST V1.1;\n  7. Tumor tissue samples were confirmed to be Claudin18.2 positive by immunohistochemical (IHC) detection, and positive was defined as ≥1+ by IHC detection (only applicable to patients in the dose escalation phase of 60μg\u002Fkg or above and in the dose expansion phase);\n  8. Adequate organ function before the first administration of the test drug (no blood components, cell growth factors, whitening drugs, platelet enhancing drugs, etc., have been used within 14 days before the first administration) 1.Absolute neutrophil count ≥1.5×109\u002FL; 2.Platelet ≥100×109\u002FL; 3.Hemoglobin ≥90g\u002FL; 4.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for liver cancer or liver metastasis, ≤5×ULN); Total bilirubin (TBIL) ≤1.5×ULN (liver cancer or liver metastasis, ≤3×ULN); 5. Serum creatinine (Cr) ≤1.5×ULN, creatinine clearance (CLcr) ≥50mL\u002Fmin when Cr \\> 1.5×ULN (CLcr was calculated using Cockcroft-Gault equation); 6.Activated partial thromboplastin time (APTT) ≤1.5×ULN, International Normalized ratio (INR) ≤1.5×ULN.\n  9. Understand and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Study participants with any of the following were not eligible for the study:\n\n  1. Received any antitumor therapy within 4 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is shorter);\n  2. Had undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the trial drug, or required elective surgery during the trial;\n  3. Received systemic corticosteroid (systemic corticosteroid equivalent to prednisone \\>10mg daily) or other immunosuppressive therapy within 2 weeks prior to the first use of the experimental drug;\n  4. Prior to first administration of the investigational drug, all reversible adverse effects of previous antitumor therapy did not return to CTCAE v5.0 rating ≤1, excluding alopecia (any grade) and ≤2 peripheral sensory neuropathy or other toxicities deemed by the investigators to be of no safety risk;\n  5. Received dual antibody or CAR-T drug therapy targeting Claudin18.2 within 3 months before the first use of the experimental drug;\n  6. have an active autoimmune disease and have had systemic systemic treatment within 3 months prior to the first use of the trial drug;\n  7. Patients with clinical symptoms of central nervous system metastasis and other evidence of uncontrolled central nervous system metastasis were judged by the investigators to be unsuitable for inclusion; Any meningeal metastases;\n  8. Subjects with a known history of severe hypersensitivity to other monoclonal antibodies or intravenous gamma globulin, and a known history of hypersensitivity or hypersensitivity to LNF2007 components;\n  9. have a severe systemic active infection that currently requires systemic anti-infection therapy;\n  10. Patients with active gastrointestinal bleeding or other gastrointestinal diseases deemed unsuitable for inclusion by researchers as having high risk factors for gastrointestinal bleeding, such as active gastrointestinal perforation requiring clinical intervention, pyloric obstruction, complete or incomplete intestinal obstruction, etc.;\n  11. There are clinical symptoms of pleural effusion, pericardial effusion or ascites requiring frequent drainage (≥1 time\u002Fmonth);\n  12. Impaired heart function or suffering from major cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  \u003C!-- -->\n\n  1. myocardial infarction, unstable angina pectoris, cerebrovascular accident, acute or persistent myocardial ischemia, symptomatic heart failure (grade 2 or higher according to the New York Heart Association Functional Scale), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolism event in the six months prior to initial administration;\n  2. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to the first dose;\n  3. aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis and other major vascular diseases that may be life-threatening or require surgery within 6 months;\n  4. Previous history of myocarditis and cardiomyopathy;\n  5. Left ventricular ejection fraction (LVEF) \\\u003C 50%; 13) Patients currently suffering from interstitial lung disease or pulmonary fibrosis, pneumoconiosis, radiation pneumonia, severe impairment of lung function, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity; 14) Hepatitis B patients (if HBsAg and\u002For HBcAb positive and HBV-DNA≥200IU\u002Fml (or 1000cps\u002Fml)); Hepatitis C patients (HCV antibody positive and HCV-RNA testing indicates viral replication); Syphilis screening positive (specific antibody test positive, non-specific antibody test negative and combined with clinical judgment confirmed as inactive infection), known HIV positive history or HIV screening positive; 15) The patient is known to have a history of psychotropic substance abuse, alcohol abuse or drug use; 16) Pregnant or lactating women, female subjects of childbearing age, or male subjects with partners of women of childbearing age who did not consent to contraception during the study period and within 6 months after the last study drug treatment; 17) Two or more malignancies in the 5 years prior to the first dose. With the exception of early stage malignancies that have been cured (carcinoma in situ or stage I tumours), such as carcinoma in situ of the cervix, basal cell or squamous cell skin cancer that has been adequately treated; 18)Patients who were not suitable for enrollment according to the judgment of the investigator.","75 Years",{"count":49,"type":20},94,[23],"A non-randomized, open-ended, phase I dose-escalation and dose-expansion study was designed to evaluate the safety, tolerability, antitumor efficacy, PK and immunogenic characteristics of LNF2007 in patients with advanced solid tumors",[26],"NOT_YET_RECRUITING","2024-12-22",{"date":56,"type":31},"2024-12-30",{"date":58,"type":20},"2025-01-20",{"date":60,"type":20},"2026-12",{"name":62,"class":38},"Shandong New Time Pharmaceutical Co., LTD"]