[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tumor-solid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tumor-solid":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,45,78,101,122,154,176,241,265,285,300,323,352,374,405,429,445,466,492,519,543,565,590],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100511721","phase-2-phase-ii-study-of-intensity-modulated-radiotherapy-in-dose-painting-for-sinus-carcinomas-after-endoscopic-surgery-100511721",false,"NCT05943119","Phase II Study of Intensity Modulated Radiotherapy in Dose Painting for Sinus Carcinomas After Endoscopic Surgery","SinocaRT","Inclusion Criteria:\n\n* Patients \\>18 years of age\n* Patient with a histologically confirmed malignant tumor of the sinuses, any histological type except melanoma, lymphoma, mesenchymal tumors (sarcoma)\n* Patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy\n* Indication for radiotherapy treatment (photontherapy or protontherapy), without neoadjuvant chemotherapy (concomitant chemotherapy is permitted)\n* Signature of informed consent prior to any specific study procedure\n* Subject affiliated to a social security system\n\nExclusion Criteria:\n\n* Patient with not operated in place tumor\n* Patient with distant metastases\n* Patient treated with neoadjuvant chemotherapy\n* Pregnant or breast-feeding woman or absence of contraception during genital activity\n* History of any other malignant disease in the last 3 years, except basal cell skin cancer, carcinoma in situ or superficial bladder tumor. Any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no sign of recurrence for at least 3 years.\n* Simultaneous participation in another therapeutic clinical trial\n* Patients deprived of their liberty, under guardianship, under curatorship, or subject to a legal protection measure, or unable to express their consent.\n* Patients unable to undergo trial monitoring for geographical, social or psychopathological reasons","ALL","18 Years",{"count":19,"type":20},52,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The patient is randomized to one of the following groups:\n\n* Experimental group: Radiotherapy in painting dose on histoscannographic mapping\n* Control group: standard pan-sinus radiotherapy",[26],"Tumor, Solid",[28,29,30,31],"IMRT","sinus","nasal","Mucosal toxicity","RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":36},"2024-03-11",{"date":40,"type":20},"2029-03",{"name":42,"class":43},"Centre Francois Baclesse","OTHER",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":44},"100396514","phase-1-an-open-label-study-of-inv-1120-as-a-single-agent-and-in-combination-with-pembrolizumab-in-adult-patients-with-advanced-solid-tumors-100396514","NCT04443088","An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors","A Phase 1a\u002F1b, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors","KEYNOTE-E12","Inclusion Criteria:\n\n1. Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses;\n2. Patient must be ≥18 years-of-age at the time of signature of the informed consent form (ICF);\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;\n4. Patients with histologically or cytologically confirmed advanced solid tumors which have progressed on or following standard therapy or for which no standard therapy exists;\n5. Patients with life expectancy ≥3 months;\n6. Patients with at least one measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), according to RECIST v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated;\n7. Patients whose laboratory data at screening meet the acceptable criteria for bone marrow, liver function and renal function.\n8. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test during screening. A woman is considered of childbearing potential (fertile) following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Postmenopausal women can be included;\n9. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 3 months following last dose. Medically acceptable contraception includes:\n\n   * Hormonal methods (Needs to have been instituted at least 1 month prior to the first dose of study drug):\n   * Barrier methods:\n   * Abstinence, defined as refraining from sexual intercourse\n10. Male patients must also refrain from donating sperm from the first dose of study drug until 4 months after the last dose of study drug;\n11. Patients must be able to swallow and retain orally administered medication.\n\nExclusion Criteria:\n\n1. History (≤5 years) or current evidence of cancer that is histologically distinct from the cancer under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer. Patients with hepatocellular carcinoma will be excluded from Phase 1b dose escalation;\n2. Known serious allergy to investigational drug or excipients (microcrystalline cellulose);\n3. History of severe autoimmune disease (including significant ongoing immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \\>10 mg\u002Fday or equivalent);\n4. Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastases having been treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage and off any systemic corticosteroids for at least 4 weeks prior to signing the consent;\n5. History (within 4 weeks of starting treatment) or evidence of active infections (Grade ≥2);\n6. Seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at any time before the start of treatment: Testing for seropositive status during screening will be at the discretion of the Investigator in patients without previously reported results;\n7. History or evidence of any severe and\u002For uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study, such as any disorder or surgical procedure that could impact the absorption of study drug from the gastrointestinal tract.\n8. History (≤6 months before the start of treatment) or evidence of any of the following: acute myocardial infarction, unstable angina pectoris, coronary artery bypass graft, cerebrovascular accident, or transient ischemic attack;\n9. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n\n   * Congenital long QT syndrome;\n   * Significant ventricular or supraventricular arrhythmias (patients with sinus arrhythmia or chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible);\n   * LVEF \\\u003C 50% by ECHO or MUGA;\n   * Other clinically significant heart disease such as known congestive heart failure New York Heart Association (NYHA) Class III-IV;\n10. Patients with QT interval ≥470 msec in females and ≥450 msec in males at screening using Fridericia's formula (determined as the mean of 3 QTcF values from the screening triplicate ECG obtained with adequate quality);\n11. Women who are pregnant or breastfeeding.\n12. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy for at least 1 month before the first dose of the study drug, during the study, and for 4 months after the last dose of study drug;\n13. Male patient who plans to father a child while enrolled in this study or within 4 months after the last dose of study drug;\n14. Not recovered from toxicity from prior anticancer therapy to baseline or Grade 1 (except toxicities which are not clinically significant such as alopecia, skin discoloration).\n15. History of an allogeneic bone marrow or solid organ transplant;\n16. Use of systemic anti-cancer agent (except luteinizing hormone-releasing hormone (LHRH) agonists, bisphosphonates and denosumab) or investigational drug ≤28 days or five half-lives whichever is shorter prior to the first dose of study treatment;\n17. Radiation therapy ≤28 days prior to the first dose of study treatment, or likely to require radiation therapy at any time until the 30 days after the last dose of study treatment, except for palliative radiation therapy limited to non-target bone lesions;\n18. Major surgery within 4 weeks before enrollment or surgery with ongoing post-operative complications);\n19. History of transfusion of platelets ≤2 weeks before the start of treatment;\n20. Patients who start erythropoietin or granulocyte-colony stimulating factor (G-CSF), pegfilgrastim, or filgrastim ≤3 weeks before screening;\n21. Patients taking medications known to have a significant risk of causing Torsades de Pointes. Patients who have discontinued any of these medications must have a wash-out period of at least 7 days or at least 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug.\n22. History of use of H2 blockers (\\\u003C24 hours before the first dose of study treatment and during the study) and proton pump inhibitors (\\\u003C5 days before the first dose of study treatment and during the study).\n23. Patients with recent (within past 12 months) history, or are currently being treated for gastroesophageal ulcer.\n\n    The following additional exclusion criteria will apply to patients enrolling in Phase 1b:\n24. Have been discontinued treatment due to a Grade 3 or higher immune-related (irAE) from prior anti-PD-1 or anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137) (only for dose expansion).\n25. Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of administration of investigational products.\n26. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines are allowed.\n27. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n28. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease or radiation pneumonitis.",{"count":54,"type":20},78,[56],"PHASE1","Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.",[59,60,61,62,63,26],"Cancer","Solid Tumor, Adult","Cancer Metastatic","Solid Carcinoma","Solid Tumor, Unspecified, Adult",[65,66,59,67],"Ionova","Ionova Bio","Oncology","2026-03-16",{"date":70,"type":36},"2026-03-18",{"date":72,"type":36},"2020-06-26",{"date":74,"type":20},"2026-12-31",{"name":76,"class":77},"Shenzhen Ionova Life Sciences Co., Ltd.","INDUSTRY",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":98,"locationsCount":100},"100572202","standardized-nutritional-management-of-pediatric-patients-with-solid-tumors-100572202","NCT06730204","Standardized Nutritional Management of Pediatric Patients With Solid Tumors","Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study","1. Male and female, age 0-18 years old\n2. Pathological diagnosis is malignant solid tumor with untreated initial onset",{"count":86,"type":20},400,[88],"NA","The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors.\n\nAfter admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. Basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.",[26,91,92],"Children","Nutritional Intervention","2026-03-13",{"date":68,"type":36},{"date":96,"type":36},"2023-07-01",{"date":74,"type":20},{"name":99,"class":43},"Children's Hospital of Fudan University",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":100},"100418061","phase-1-tumorglow-intraoperative-molecular-imaging-imi-100418061","NCT04723810","TumorGlow Intraoperative Molecular Imaging (IMI)","A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)","Inclusion Criteria:\n\n* Adult patients 18 years of age or older.\n* Patients presenting with any solid tumor and\u002For diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment.\n* Good operative candidate as determined by the treating physician and\u002For multidisciplinary team.\n* Subject capable of giving informed consent.\n\nExclusion Criteria:\n\n* Subject unable to participate in the consent process.\n* Vulnerable population including pregnant women, prisoners, and children.\n* History of uncontrolled hypertension (e.g., history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications)\n* Patients with a self-reported history of iodide allergies.",{"count":109,"type":20},500,[56,23],"This is a Phase 1\u002F2 study in patients presenting with any solid tumor and\u002For diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.",[26],"2026-03-05",{"date":115,"type":36},"2026-03-09",{"date":117,"type":36},"2024-08-14",{"date":119,"type":20},"2027-01-14",{"name":121,"class":43},"University of Pennsylvania",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":141,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":151,"locationsCount":153},"100626257","phase-1-carbon-nanoparticle-loaded-iron-in-the-treatment-of-advanced-solid-tumor-100626257","NCT07433283","Carbon Nanoparticle-Loaded Iron in the Treatment of Advanced Solid Tumor","A Phase Ib\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of Intratumoral Injection of Carbon Nanoparticle-Loaded Iron Suspension Injection [CNSI-Fe(II)] With Multiple Administrations in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be eligible:\n\n1. Understand and voluntarily sign the written informed consent form (ICF), be willing and able to comply with all trial requirements;\n2. Male or female aged 18\\~80 years old (including cut-off value) at the time of signing the ICF;\n3. Stage Ib: patients with advanced solid tumors confirmed by histology or cytology, and the current standard therapy is ineffective (disease progression after treatment or treatment is not tolerated) or there is no effective standard treatment, such as soft tissue sarcoma, refractory thyroid cancer, colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, cervical cancer, lung cancer, head and neck cancer, liver cancer, bile duct cancer, kidney cancer, prostate cancer, vulvar cancer, etc.; Note: Subjects with advanced solid tumors whose disease progresses due to no standard therapy for any reason, or advanced solid tumors whose disease has progressed after receiving the first course of standard therapy for tumor types that are not sensitive to existing standard therapies (e.g., pancreatic cancer, undifferentiated thyroid cancer, sarcoma, etc.) can be included.\n4. At least one measurable lesion according to RESICT v1.1 and the lesion has not previously undergone radiotherapy (unless the lesion has clearly progressed after radiotherapy) and has not undergone a tissue biopsy within 7 days prior to screening;\n5. Have injectable lesions (such as direct injection or assisted injection by medical imaging instruments), which are judged by the investigator to be suitable for repeated intratumoral injection;\n6. The ECOG score within 7 days before the first dose is 0\\~1 points;\n7. Expected survival ≥ 3 months;\n8. Adverse drug reactions (ADRs) caused by prior therapy have recovered to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria grade 1 and below before screening (alopecia, grade 2 or below peripheral neurotoxicity, etc., except for toxicities judged by the investigator to be of low safety risk);\n9. Left ventricular ejection fraction (LVEF) ≥50%;\n10. Within 7 days prior to the first dose, adequate hematologic and end-organ function with laboratory tests meeting the following criteria:\n\n    haematology No treatment with granulocyte colony-stimulating factor (G-CSF) within 14 days prior to hematology laboratory tests, and absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Have not been treated with platelet transfusion or interleukin-11 (IL-11) or recombinant human thrombopoietin injection before hematological laboratory examination, and the platelet count (PLT) ≥ 90×109\u002FL; No blood transfusion or erythropoietin within 14 days prior to hematology laboratory tests, and hemoglobin (Hb) ≥ 90 g\u002FL; Kidney function Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or 50 mL\u002Fmin (Cr only) calculated using the Cockcroft-Gault formula (Cr) 50 mL\u002Fmin (Cr ≥\\> only). 1.5 Calculate Ccr when ×ULN); Liver function TBIL ≤ 1.5× ULN (3.0 ≤× ULN for subjects with Gilbert's syndrome or liver metastases);\n\n    AST, ALT, and ALP≤3×ULN, and subjects with confirmed liver metastases or bone metastases must meet the following conditions:\n\n    Subjects with confirmed liver metastases: AST and ALT≤5×ULN; Subjects with confirmed bone metastases: ALP≤5×ULN; serum albumin≥ 2.8 g\u002FdL; Coagulation function International normalized ratio (INR) or prothrombin time (PT) and aPTT ≤1.5×ULN; Note: Subjects receiving anticoagulant medication are allowed to prolong their INR, PT and aPTT if the injected lesion is in the skin and\u002For subcutaneous, because excessive bleeding can be controlled by applying direct pressure, at the discretion of the investigator; Subjects receiving anticoagulant therapy are advised to discontinue anticoagulant medication for at least 1 week before deep lesion injection, at the discretion of the investigator.\n11. Female subjects of childbearing potential (WOCBP) who must have a negative serum pregnancy test result within 7 days prior to the first dose of study drug and a commitment to adequate and effective contraception or abstinence during treatment with study drug and for 6 months after the end of study drug treatment. In addition, female subjects must be non-lactating.\n\n    Note: WOCBP is defined as non-postmenopausal women who have experienced menarche but have not yet undergone sterilization surgery (hysterectomy or bilateral salpingectomy). Postmenopausal is defined as meeting any of the following conditions: (1) prior bilateral oophorectomy; (2) Age≥ 60 years old; (3) Age \\\u003C 60 years and have been out of menstruation for 12 months or more without chemotherapy and taking tamoxifen, toremifene and ovarian function suppression therapy; (4) If taking tamoxifen or toremiaphene and \\\u003C age 60 years, FSH and plasma estradiol levels must be in the postmenopausal range.\n\n    Hormone replacement therapy (HRT) may artificially suppress FSH levels in women and may require a washout period to return to physiological FSH levels. The duration of the washout period is one of the effects of the HRT type. The following washout period duration is recommended as a guideline, and the investigator should judge the results of the serum FSH level on his own.\n\n    vaginal hormonal preparations (drug rings, creams, gels) for at least 1 week; transdermal preparation for at least 4 weeks; Oral preparation for at least 8 weeks; Other parenteral preparations may require a washout period of up to 6 months. If the serum FSH level \\> 40 mIU\u002FmL during the washout period, a postmenopausal woman may be considered.\n12. Male subjects commit to adequate and effective contraception or abstinence during study drug treatment and for 6 months after the end of study drug treatment. In addition, male subjects must agree not to donate sperm during this period.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria cannot participate in this clinical study:\n\n1. Previous or current diseases with abnormal iron metabolism (except for subjects with iron deficiency anemia), such as thalassemia, fava bean disease (erythrocyte glucose-6-phosphate dehydrogenase deficiency), etc.;\n2. Signs of perforation of hollow viscera at the previous or current injection site;\n3. Previous or current injection site with local skin breakdown, redness, swelling, necrosis, bleeding, etc., which affects the injection of study drugs;\n4. Systemic chemotherapy, targeted therapy, anti-tumor biologic therapy, or immunotherapy within 3 weeks prior to the first dose of study drug; Prior radiotherapy within 14 days prior to the first dose of study drug (with the exception of central nervous system \\[CNS\\] radiotherapy, which requires a washout period of ≥ 28 days); Received traditional Chinese medicine with anti-tumor indications within 2 weeks before the first dose of the study drug;\n5. Major surgery within 4 weeks prior to the first dose of study drug or unhealed wounds, ulcers, or fractures (except for minor surgeries performed within 1 week and full recovery);\n6. Untreated or with active brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence that the subject's brain or spinal cord metastases have not been controlled (except for those who have been treated and have stable symptoms, have been stable for at least 4 weeks before the first dose on imaging tests, and have no evidence of cerebral edema, and do not require glucocorticoid therapy);\n7. Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg);\n8. Uncontrolled tumor-related pain;\n9. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once\u002Fmonth or more often);\n10. Active malignancy within 5 years prior to the first dose of study treatment, with the exception of non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer, cervical carcinoma in situ, or carcinoma in situ of the breast that has received curative therapy;\n11. Vaccination with a live virus vaccine within 4 weeks prior to the first dose of study treatment; Note: Seasonal influenza vaccines for injection are usually inactivated influenza vaccines and are permitted; However, intranasal influenza vaccine is a live attenuated vaccine and is not allowed.\n12. Those with a history of immunodeficiency, including human immunodeficiency virus (HIV) positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;\n13. Active hepatitis B virus (HBV) infection (HBV DNA quantification \\>500 IU\u002FmL), hepatitis C virus (HCV) infection (HCV antibody positive and polymerase chain reaction \\[PCR\\] of HCV ribonucleic acid \\[RNA\\] exceeds ULN), positive anti-human immunodeficiency virus antibody (Anti-HIV). Those who meet any of the above items;\n14. Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy prior to the start of study treatment; Note: Subjects with viral hepatitis are allowed to receive antiviral therapy.\n15. History of severe cardiac insufficiency, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment. History of ventricular tachycardia or torsade de pointes. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG. Has clinically significant cardiac disease, including acute myocardial infarction, Class III or IV congestive heart failure (New York Heart Association classification, see Appendix 5 for details), unstable angina, or cardiac arrhythmia requiring treatment that occurred within 6 months prior to the first dose of study treatment. Note: Subjects with arrhythmias who are receiving anti-arrhythmic drugs and have a controlled heart rate rhythm on screening ECG can be enrolled.\n16. Have an active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder, etc.);\n17. Subjects who are known to be allergic or intolerant to the active ingredient or excipient of the study drug;\n18. Have participated in other interventional clinical studies within 3 weeks prior to the start of study treatment administration (calculated from the first day after the last dose of the previous study, except for those who have not used interventional drugs or investigational medical devices);\n19. Other conditions judged by the investigator to be unsuitable for participation in this trial","80 Years",{"count":131,"type":20},54,[56,23],"Independently developed by Sichuan Yingrui Pharmaceutical Technology Co., Ltd., CNSI-Fe is an innovative anti-cancer drug with Fe2+ as the active ingredient, which exerts anti-tumor effects by regulating the ferroptosis pathway. CNSI-Fe intratumoral injection has the following three effects: 1. Nanocarbon can increase the content of hydrogen peroxide in tumor cells and tumor microenvironment, and is a reactive oxygen species that catalyzes hydrogen peroxide through the Fenton reaction of iron ions to produce \"ferroptosis\", which complements each other; 2. The adsorption of Fe2+ by nanocarbon can help Fe2+ better enter the cell, thereby exerting anti-tumor effects; 3. The lesion localization and lymphatic tracing functions of nanocarbon are retained. The combination of the regulatory mechanism of ferroptosis and the characteristics of nanocarbon particles has increased the advantages of new nanopharmaceuticals in cancer prevention and treatment.\n\nAt present, CNSI-Fe has carried out a first-in-human phase I clinical trial of dose escalation in subjects with advanced solid tumors in China, and has conducted safety and efficacy exploration in four dose groups, including: 30 mg, 60 mg, 90 mg, and 120 mg, and the overall safety and tolerability of the 16 subjects enrolled have been good, no obvious liver and kidney impairment and hematologic toxicity have been observed, and only one subject in the 90 mg dose group has a dose-limiting toxicity (DLT) event; Partial response (PR) was observed in 1 subject (30 mg group), complete tumor response (CR) was observed in 1 subject (60 mg group), and stable tumor (SD) was observed in 11 subjects (including 1 in the 30 mg group, 2 in the 60 mg group, 5 in the 90 mg group, and 3 in the 120 mg group), and the disease control rate (DCR) of the trial treatment was 87%. This Phase I clinical study is planned to continue dose exploration at 150 mg or higher.\n\nTherefore, based on the results of the Phase I clinical trial obtained, it is planned to conduct this Phase Ib\u002FIIa clinical study in subjects with advanced solid tumors in China to further evaluate the safety, tolerability, pharmacokinetic (PK) characteristics and preliminary efficacy of CNSI-Fe intratumoral injection and multiple administration, so as to provide a basis for clinical development in the later stage.",[26,135,136,137,138,139,140],"Lung Cancer","Pancreas Cancer","Thyroid Cancer","Colorectal Cancer","Cervical Cancer","Vulva Cancer",[142,143,144],"Intratumoral Injection","Carbon Nanoparticle-Loaded Iron","Advanced Solid Tumor","2026-02-24",{"date":147,"type":36},"2026-02-25",{"date":149,"type":36},"2024-11-12",{"date":74,"type":20},{"name":152,"class":43},"Sichuan Enray Pharmaceutical Sciences Company",9,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":100},"100619701","phase-1-study-of-rgl-270-single-drug-and-combined-with-adebelimab-in-patients-in-patients-at-high-risk-of-recurrence-after-radical-treatment-of-malignant-solid-tumors-100619701","NCT07348042","Study of RGL-270 Single Drug and Combined With Adebelimab in Patients in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors","An Open, Multi-center Phase I Clinical Study Evaluating the Safety, Tolerance, Pharmacokinetics and Immunogenicity of RGL-270 Single Drug and Combined With Adebelimab in Patients at High Risk of Recurrence After Radical Treatment of Malignant Solid Tumors","Inclusion Criteria:\n\nPre-screening period\n\n1. Subjects should understand and abide by the relevant research procedures, and voluntarily sign the prior informed consent form;\n2. Age 18-75 years old (including boundary value), gender is not limited;\n3. For malignant solid tumors confirmed by histology or cytology after radical resection, the subjects are allowed to complete standard adjuvant treatment, or no standard adjuvant treatment, or adjuvant treatment intolerance before receiving the first administration of this study:\n4. Willing to provide sufficient tumor tissue specimens and peripheral blood for genetic testing and new antigen analysis;\n5. Fertile female subjects and male subjects whose partners are women of childbearing age must agree to comply with the contraceptive requirements for 6 months from the signing of the pre-informed consent form until the end of the last treatment.\n\nScreening period\n\n1. Subjects should understand and abide by the relevant research procedures, and voluntarily sign the owner's informed consent form;\n2. Eastern American Oncology Collaborative Group (ECOG) score: 0 or 1 point;\n3. Willing to provide blood samples needed to detect immunogenicity and biomarkers before and after drug treatment;\n4. The functions of important organs meet the following criteria (no blood components and cell growth factors have been used within 14 days before the start of research and treatment):\n\n   A) Blood routine: neutrophil count (ANC) ≥1.5×109\u002FL, lymphocyte count (LYM) ≥0.5×109\u002FL, platelet count (PLT) ≥1× normal lower limit (LLN), hemoglobin (Hb) ≥90g\u002FL; B) Blood biochemical: total bilirubin (TBIL) ≤1.5× normal upper limit (ULN), glutathione transaminase (ALT) and glutathione transaminase (AST) ≤2.5×ULN, serum albumin (ALB) ≥30g\u002FL, serum creatine (Scr) ≤1×ULN; C) Coagulation routine: International Standardized Ratio (INR) ≤1.5, activated partial prothrombin time (APTT) ≤1.5×ULN; D) Heart function: Left ventricular blood ejection fraction (LVEF) ≥50%; E) Electrocardiogram: The QT interval (QTcF) corrected by Fridericia method is \\\u003C470 milliseconds; the QTc interval must be corrected according to Fridericia's standard, and the correction formula QTcF=QT\u002FRR\\^0.33.\n5. Clinical examination, chest and abdomen CT and head MRI baseline radiological evaluation within 14 days before the first vaccine administration showed no evidence of disease recurrence;\n6. Fertile female subjects must take a serum pregnancy test within 7 days before the first vaccination, and the result is negative and must be non-lactating.\n\nExclusion Criteria:\n\n* Pre-screening period\n\n  1. Have received immune cell or tumor vaccine treatment, including but not limited to tumor infiltration lymphocytes (TILs), chimeric antigen receptor T cells (CAR-T), T cell receptor chimeric T cells (TCR-T) and therapeutic tumor vaccines;\n  2. Plan to inoculate live attenuated vaccine during the screening period or during the research period and within 90 days after the end of the research drug treatment (inactivated vaccine is allowed);\n  3. Anyone who is evaluated by researchers as not suitable for immunotherapy;\n  4. There is an autoimmune disease (except for hypothyroidism who need hormone replacement treatment caused by autoimmune thyroiditis);\n  5. Known history of epilepsy or other symptomatic neurological diseases;\n  6. Known history of psychotropic substance abuse, alcoholism or drug abuse;\n  7. There is evidence of active tuberculosis infection within 1 year before the pre-screening period and during the pre-screening period, whether it is treated or not;\n  8. Subjects with known or suspected interstitial pneumonia, or evidence of interstitial pneumonia in the chest CT during the pre-screening period; known history of idiopathic pulmonary fibrosis, mechanized pneumonia (such as occlusive bronchitis or occult mechanized pneumonia);\n  9. Combined history of other malignant tumors within 5 years before the pre-screening period;\n  10. Known history of allogeneic organ transplantation or history of allogeneic hematopoietic stem cell transplantation;\n  11. Known allergy to research drugs or any of their auxiliaries, or a history of severe allergic reactions to other vaccines;\n  12. Suffering from congenital or acquired immunodeficiencies, such as cellular immunodeficiencies (such as DiGeorge syndrome, T-negative severe combined immunodeficiency \\[SSCID\\]) or combined T-cell and B-cell immunodeficiency (such as T- and B-negative combined immunodeficiency, Wiskott-Al Drich syndrome, ataxia telangiectasia, common variable immunodeficiency); or infected with human immunodeficiency virus (HIV);\n  13. Poorly controlled or severe cardiovascular and cerebrovascular diseases: congestive heart failure (NYHA standard III or level IV), severe arrhythmia requiring treatment or intervention, and poorly controlled hypertension after full treatment (systolic pressure ≥160mmHg, diastolic pressure ≥100mmHg );\n  14. Pregnant or lactating female subjects;\n  15. The data analysis results of tumor tissue sequencing show that there are not enough new antigens available for vaccine preparation or vaccine preparation fails;\n  16. The researcher judges that the subject may not be able to continue to participate in the study:\n* Any other disease in which the subject faces the risk of safety;\n* Subjects with poor compliance or active request to withdraw from pre-screening;\n* There is a recurrence of the disease during the pre-screening period. Screening period\n\n  1. Postoperative complications have not recovered, or the complications are higher than the Clavien-Dindo complication grade 2;\n  2. The toxicity caused by auxiliary treatment before the first vaccine administration has not recovered to the baseline level or \\>1 (except for hair loss and pigmentation), and the neurotoxicity is \\>2;\n  3. There is evidence of active tuberculosis infection during the screening period, whether it is treated or not;\n  4. Chest CT during the screening period suggests evidence of interstitial pneumonia;\n  5. Concurrent severe infection within 28 days before the first vaccination (such as intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment standards);\n  6. Within 28 days before the first vaccination, there is pleural fluid or ascites that are not clinically controlled and require thoracic puncture or abdominal puncture drainage;\n  7. Active hepatitis B (defined as active hepatitis B virus surface antigen \\[HBsAg\\] test results during the screening period are positive and HBV DNA≥500IU\u002FmL or higher than the upper limit of the normal detection value of the research center), or hepatitis C (defined as hepatitis C antibodies during the screening period \\[HCV -Ab\\] The test result is positive, and HCV-RNA is positive);\n  8. Myocardial infarction or stroke occurred within 3 months before the first vaccination (except for transient cerebral ischemia and cavity cerebral infarction), or unstable angina pectoris within 1 month;\n  9. Arteriovenous thrombosis, such as deep vein thrombosis or pulmonary embolism, occurred within 3 months before the first vaccination;\n  10. The researcher judges other circumstances that may affect the progress of clinical research and the results.","75 Years",{"count":163,"type":20},198,[56],"This study is a phase I clinical trial of multi-center, open label, dose increase and dose expansion. It aims to evaluate the safety, tolerance, PK characteristics, immunogenicity and initial efficacy of personalized new antigen mRNA vaccine RGL-270 (hereinafter referred to as RGL-270) alone and combined with adebelizumab in patients with high risk of recurrence of malignant solid tumors after radical treatment.",[26],"2026-01-09",{"date":169,"type":36},"2026-01-16",{"date":171,"type":36},"2025-09-07",{"date":173,"type":20},"2027-12-31",{"name":175,"class":43},"Xian-Jun Yu",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":202,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100517783","phase-1-a-dose-escalation-and-dose-expansion-study-of-intratumoral-onm-501-alone-and-in-combination-with-cemiplimab-in-patients-with-advanced-solid-tumors-and-lymphomas-100517783","NCT06022029","A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.","A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas","ON-5001","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign written informed consent before performance of any study procedures\n2. Age ≥ 18 years\n3. Participants with solid tumors or lymphomas, confirmed by available histopathology records or current biopsy, that are advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists.\n4. Participants must have a minimum of one injectable and measurable lesion.\n5. Participants with prior Hepatitis B or C are eligible if they have adequate liver function\n6. Participants with human immunodeficiency virus (HIV) are eligible if on established HAART for a minimum of 4 weeks prior to enrollment, have an HIV viral load \\\u003C400 copies\u002FmL, and have CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FuL\n7. Adequate bone marrow function:\n8. Adequate liver function\n\nExclusion Criteria: Patients will be excluded from this study if they meet any of the following criteria (Part 1a and Part 1b).\n\n1. Other malignancy active within the previous 2 years except for basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy.\n2. Major surgery within 4 weeks before the first dose of study drug.\n3. Brain metastases that are untreated or in the posterior fossa or involve the meninges. Participants with stable or previously treated progressing brain metastases (except in the posterior fossa or involving the meninges) may be permitted in a case-by-case basis at the Sponsor's discretion.\n4. Prolongation of corrected QT (QTc) interval to \\>470 millisecond (ms) for males and females when electrolytes balance is normal.\n5. Females who are breastfeeding or pregnant at screening or baseline\n6. Females of childbearing potential that refuse to use a highly effective method of contraception.\n7. Has uncontrolled or poorly controlled hypertension as defined by a sustained BP \\> 9. Has received prior investigational therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter.\n8. Has had any major cardiovascular event within 6 months prior to study drug 10. Has known hypersensitivity to any component in the formulation of ONM-501\n9. Has an active infection requiring systemic treatment\n10. Is participating in another therapeutic clinical trial\n\nAdditional Exclusion Criteria for ONM-501 in Combination with cemiplimab (Part 1b)\n\n1. Has known hypersensitivity to any component in the formulation of cemiplimab\n2. Has any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\>10 mg daily prednisone equivalent)\n3. Has a condition requiring systemic treatment with corticosteroids",{"count":185,"type":20},168,[56],"A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and\u002For recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.",[189,190,191,192,193,194,195,196,197,198,199,200,26,201],"Triple Negative Breast Cancer","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Lymphoma, Non-Hodgkin","Mantle Cell Lymphoma","Bladder Cancer","Uveal Melanoma, Recurrent","Cervix Cancer","Carcinoma in Situ","Head and Neck Squamous Cell Carcinoma","Skin Cancer","Metastatic Cancer","Tumor Recurrence",[203,204,205,206,207,208,209,210,199,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230],"Solid tumors","Lymphoma","ONM-501","STING","Intra-tumoral","HNSCC","Breast Cancer","Melanoma","cemiplimab","Libtayo","DLBCL","bladder cancer","cervical cancer","metastases","immunotherapy","ICI","TNBC","Triple Negative","mTNBC","anti-PD-1 antibody","BRCA1","BRCA2","anti-PD-L1","uveal","NHL","Mantle Zone lymphoma","FL","stimulator of interferon genes","2025-12-18",{"date":233,"type":36},"2025-12-24",{"date":235,"type":36},"2023-10-13",{"date":237,"type":20},"2026-08-29",{"name":239,"class":77},"OncoNano Medicine, Inc.",16,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":249,"phases":4,"briefSummary":250,"conditions":251,"keywords":254,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":100},"100524999","immune-profiling-for-cancer-immunotherapy-response-100524999","NCT06116032","Immune Profiling for Cancer Immunotherapy Response","Inclusion Criteria:\n\n* Cancer patients receiving or will receive immunotherapy under FDA- approved indication (e.g. checkpoint inhibitor therapy with pembrolizumab, nivolumab, or ipilimumab, or cellular immunotherapy).\n* Participants are eligible regardless of the type of prior therapy (i.e. prior immunotherapy treated participants can be included).\n\nExclusion Criteria:\n\n* Pregnant women\u002Ffetuses\u002Fneonates\n* Prisoners\n* Decision-impaired individuals",{"count":248,"type":20},1500,"OBSERVATIONAL","In patients clinically treated with FDA-approved immunotherapy the investigators will assess the predictive value of pre- and on-treatment 1) immune-methylation profiling across cancer types, and 2) immune-methylation profiling and cytokine profiling within cancer types.",[59,26,252,253],"Hematologic Malignancy","Blood Cancer",[255],"Immunotherapy","2025-12-09",{"date":258,"type":36},"2025-12-16",{"date":260,"type":36},"2022-10-03",{"date":262,"type":20},"2029-01-01",{"name":264,"class":43},"Dartmouth-Hitchcock Medical Center",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":100},"100553338","phase-1-t-cell-receptor-gene-engineered-t-cell-therapy-targeting-kras-mutations-in-the-treatment-of-subjects-with-advanced-solid-tumor-100553338","NCT06484790","T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor","An Open-Label, Dose-Escalation Phase I Clinical Study of T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor","Key Inclusion Criteria:\n\n* Age between 18-75 years\n* Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments\n* HLA-A11:01positive Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation \\* Adequate organ function prior to apheresis and lymphodepleting chemotherapy\n* ECOG performance status of 0-1\n* At least one tumor lesion measurable according to RECIST 1.1 (Additional protocol-defined Inclusion criteria may apply.)\n\nKey Exclusion Criteria:\n\n* Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion\n* History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study\n* History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to enrollment\\* Have symptomic CNS metastases\n* Have leptomeningeal disease or carcinomatous meningitis\n* Have ongoing or active infection\n* Active infections with HIV, HBV, HCV, or syphilis\n* Breastfeeding or pregnant (Additional protocol-defined Exclusion criteria may apply.)",{"count":153,"type":20},[56],"An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics\u002Fpharmacodynamic (PK\u002FPD) of NW-301V and NW-301D in subjects with advanced solid tumor.",[26],"2025-11-19",{"date":278,"type":36},"2025-11-25",{"date":280,"type":36},"2024-04-08",{"date":282,"type":20},"2027-04-07",{"name":284,"class":43},"Ting Deng",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":274,"conditions":292,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":100},"100552835","phase-1-t-cell-receptor-gene-engineered-t-cell-therapy-targeting-kras-mutations-in-the-treatment-of-subjects-with-advanced-solid-tumor-100552835","NCT06478251","Key Inclusion Criteria:\n\n* Age between 18-75 years\n* Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments\n* HLA-A\\*11:01positive\n* Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation\n* Adequate organ function prior to apheresis and lymphodepleting chemotherapy\n* ECOG performance status of 0-1\n* At least one tumor lesion measurable according to RECIST 1.1\n\n(Additional protocol-defined Inclusion criteria may apply.)\n\nKey Exclusion Criteria:\n\n* Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion\n* History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study\n* History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to enrollment\n* Have symptomic CNS metastases\n* Have leptomeningeal disease or carcinomatous meningitis\n* Have ongoing or active infection\n* Active infections with HIV, HBV, HCV, or syphilis\n* Breastfeeding or pregnant\n\n(Additional protocol-defined Exclusion criteria may apply.)",{"count":153,"type":20},[56],[26],{"date":278,"type":36},{"date":295,"type":36},"2024-02-01",{"date":297,"type":20},"2027-06",{"name":299,"class":43},"TingBo Liang",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":322},"100490079","phase-1-dose-escalation-study-to-assess-safety-and-pharmacokinetics-of-nab-sirolimus-in-patients-with-locally-advanced-or-metastatic-solid-tumors-and-moderate-liver-impairment-100490079","NCT05661461","Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment","A Phase 1, Open-label, Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment","Inclusion Criteria:\n\n* For All Patients\n\n  1. Willing and able to provide informed consent and comply with protocol requirements for the duration of the study.\n  2. Male or female patients at least 18 years of age at the time of signing the informed consent form.\n  3. Histologically confirmed locally advanced or metastatic solid tumors that is measurable or non-measurable.\n  4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n  5. Adequate hematologic counts:\n\n     * Absolute neutrophil count (ANC) ≥1.0 × 109 \u002FL (growth factor support allowed)\n     * Platelet count ≥75,000\u002Fmm 3 (75 × 10 9 \u002FL) (transfusion and\u002For growth factor support allowed)\n     * Hemoglobin ≥8.0 g\u002FdL (transfusion and\u002For growth factor support allowed)\n  6. Creatinine clearance ≥30 mL\u002Fmin as assessed by the Cockcroft-Gault equation:\n\n     Creatinine Clearance ≥30 = (140 - age) × (weight\\[kg\\] \u002F (72 x SCr\\[mL\u002Fmin\\]\\_ x 0.85, if female\n  7. Fasting serum triglyceride must be ≤300 mg\u002FdL; fasting serum cholesterol must be\n\n     ≤350 mg\u002FdL.\n  8. Male or non-pregnant and non-breastfeeding female:\n\n     * Females of child-bearing potential must agree to use highly effective contraception or abstinence without interruption from 28 days prior to first dose throughout 3 months after last dose and have a negative pregnancy test (urine or serum) result at screening and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.\n     * Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and throughout 3 months after last dose. A second form of birth control is required even if he has undergone a successful vasectomy.\n  9. Minimum of 4 weeks since major surgery, completion of radiation, or completion of all prior systemic anticancer therapy, or at least 5 half-lives if the prior therapy is a single agent small-molecule therapeutic, and in either case adequately recovered from the acute toxicities of any prior therapy (including neuropathy) to Grade ≤1. For Patients with Normal Hepatic Function\n  10. Normal hepatic function (total bilirubin ≤ upper limit of normal \\[ULN\\] and aspartate aminotransferase \\[AST\\] ≤ULN). For Patients with Moderate Hepatic Impairment\n  11. Moderate hepatic impairment (total bilirubin 1.5-3.0 × ULN and any level of AST)\n\nExclusion Criteria:\n\n1. Received prior treatment with an mTOR inhibitor within 4 weeks prior to first dose.\n2. Patients who have any severe and\u002For uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:\n\n   1. Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, untreated brain metastases or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose \\[defined as dexamethasone 10 mg daily or higher\\] or increasing dose of systemic corticosteroids) and without imminent need of radiation therapy are eligible. If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and\u002For complications prior to eligibility assessment. For patients who have received prior radiation therapy, post-treatment magnetic resonance imaging (MRI) scan should show no increase in brain lesion size\u002Fvolume.\n   2. Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association, NYHA class III or IV), myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.\n   3. Pre-existing severely impaired lung function. If a patient has a pre-existing pulmonary condition, eligible patients should have a spirometry and diffusing capacity for carbon monoxide (DLCO) that is \\>50% of the normal predicted value and\u002For O2 saturation that is \\>88% at rest on room air (Note: spirometry and pulmonary function tests \\[PFTs\\] not required to be performed unless clinically indicated).\n   4. Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy. Note, controlled non melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, or other adequately treated carcinoma-in-situ may be eligible, after documented discussion with the Medical Monitor.\n   5. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg).\n   6. Patients with history of interstitial lung disease and\u002For pneumonitis, or pulmonary hypertension.\n   7. Individuals with known human immunodeficiency virus (HIV) infection are excluded from this study as combination antiretroviral therapy could potentially result in significant pharmacokinetic interactions. In addition, these individuals are at increased risk of serious infections due to the immunosuppressive effects of mTOR inhibition.\n   8. Active Hepatitis B or Hepatitis C, with detectable viral load. Note: A detailed assessment of Hepatitis B\u002FC medical history and risk factors must be done at screening for all patients.\n3. Have active severe (Grade ≥3) infection requiring intravenous (IV) antibiotics (contact medical monitor for clarification).\n4. High-dose systemic corticosteroids (\\>10 mg of prednisone or its equivalent) are not permitted within 2 weeks of first dose. However, inhaled, intranasal, intra articular, and topical steroids are allowed.\n5. Have a history of Gilbert's disease.\n6. Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.\n\n   For Patients with Moderate Hepatic Impairment\n7. Had a clinical exacerbation of liver disease within the 2-week period prior to first dose (ie, abdominal pain, nausea, vomiting, anorexia, or fever).\n8. Have clinically demonstrable, tense ascites.\n9. Had evidence of acute viral hepatitis within 1 month prior to first dose.\n10. Have evidence of hepatorenal syndrome.\n11. Have a transjugular intrahepatic portosystemic shunt.\n12. Have active stage 3 or 4 encephalopathy.",{"count":308,"type":20},28,[56],"This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.",[26,312,144],"Tumor","2025-11-12",{"date":315,"type":36},"2025-11-13",{"date":317,"type":36},"2022-11-23",{"date":319,"type":20},"2026-08-01",{"name":321,"class":77},"Aadi Bioscience, Inc.",2,{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":4,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":329,"phases":4,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":346,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":350,"locationsCount":4},"100514124","expanded-access-to-immunomodulatory-avm0703-for-solid-tumor-and-blood-cancer-patients-100514124","NCT05974410","Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer patients upon request by a US licensed MD or DO. As of July 2024, 37 patients have been treated through this FDA-EAP including patients diagnosed with relapsed or recurring glioblastoma, inoperable\u002Fchemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell Non-Hodgkin's Lymphoma and metastatic pancreatic cancer. Drug-related side-effects are predominantly grade 1 and include itching during the infusion and about 1 week of low grade insomnia.",[332,333,334,335,209,336,337,338,339,340,341,59,26,342,343,344,345],"Glioblastoma","Squamous Cell Carcinoma","Hodgkin Lymphoma","Non-hodgkin Lymphoma","Prostate Cancer","Gastric Cancer","Ovarian Cancer","Acute Leukemia","Pancreatic Cancer","Spindle Cell Sarcoma","Tumor, Brain","Esophageal Andeocarcinoma","Mixed Phenotype AML","Desmoplastic Round Cell Sarcoma","AVAILABLE","2025-09-29",{"date":349,"type":36},"2025-10-02",{"name":351,"class":77},"AVM Biotechnology Inc",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":100},"100320607","phase-1-ulixertinibpalbociclib-in-patients-with-advanced-pancreatic-and-other-solid-tumors-100320607","NCT03454035","Ulixertinib\u002FPalbociclib in Patients With Advanced Pancreatic and Other Solid Tumors","Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent (no upper age limit)\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n4. Tumor Eligibility:\n\n   1. Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care\n   2. Expansion cohort (at RP2D): metastatic pancreatic cancer or malign melanoma patients who have received at least one line of therapy in the metastatic setting\n   3. Expansion cohort (at RP2D) for histologically confirmed unresectable stage III or stage IV melanoma with the following additional eligibility requirements:\n\n      * Tumors molecular profiling genetic aberrations: NRASG12\u002FG13\u002FQ61, KRASG12\u002FG13, HRASG12\u002FG13, any amplifications of the NRAS, KRAS, or HRAS genes. For NF1 mutations, subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled.\n      * Documented disease refractory to at least one PD1\u002FPD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug.\n      * Subjects with RAS-mutant and NF1-mutant (no concurrent BRAFV600 mutations) melanoma that have not taken prior immune checkpoint inhibitors will be allowed if they are not eligible to receive prior immune checkpoint inhibitors due to requirement for immunosuppression\n5. Measurable or non-measurable (but evaluable) disease according to RECIST v1.1 for dose escalating cohorts; measurable disease as per RECIST v1.1 required for expansion cohort\n6. Life expectancy ≥ 12 weeks\n7. Recovered from all reversible acute toxic effects of last anti-cancer treatment (other than alopecia) to ≤Grade 1 or baseline. Patients with baseline neuropathy that is ≤ grade 2 are eligible for enrollment.\n8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to day -6 of ulixertinib\n\n   Hemoglobin (Hgb) ≥ 9 g\u002FdL Absolute Neutrophil Count (ANC) ≥ 1,500 \u002Fmm3 Platelets ≥ 100,000\u002Fmm3 Creatinine ≤1.5 x upper limit of normal (ULN) or Calculated creatinine clearance ≥ 60 mL\u002Fmin using the Cockcroft-Gault formula Bilirubin ≤ 1.5 x ULN Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN; if tumor involvement of the liver ≤ 5 x ULN\n\n   \\*Note: Hematology and other lab parameters that are ≤ grade 2 but still meet the criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet the criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy.\n9. Adequate cardiac function; left ventricular ejection fraction (LVEF) \\>50% as assessed by ultrasound\u002Fechocardiography (ECHO); corrected QT interval (QTc) \\\u003C470ms\n10. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to day -6 of ulixertinib. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n11. Females of childbearing potential and males must be willing to abstain from heterosexual activity\\* or use effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation. Acceptable contraception methods can be comprised of an intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin, OR use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap\u002Fspermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive.\\] \\*Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n12. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.\n13. Willing to provide archival tissue (if available) and consent to mandatory pretreatment and on-treatment biopsy as deemed safe by the treating physician (expansion cohort only) for research purposes only.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)\n2. Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of ulixertinib\n3. A history or current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).\n4. Major surgery within 28 days prior to day -6 of ulixertinib\n5. Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, oranges, pummelos, and exotic citrus fruits from 7 days prior to day -6 of ulixertinib and during the entire study due to potential CYP3A4 interaction with the study medications.\n6. Intake of any herbal preparations or medications (including, but not limited to, Saint John's Wort and ginkgo biloba) and dietary supplements within 7 days prior to day -6 of ulixertinib due to potential CYP3A4 interaction with the study medications\n7. Unable or unwilling to discontinue use of any drug known to be a strong inhibitor of CYP3A4, CYP1A2 or CYP2D6 or strong inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to day -6 of ulixertinib; see section 10.3 Appendix C)\n8. Unable or unwilling to discontinue use of any drug known to be a sensitive CYP3A4 substrate with a narrow therapeutic index as defined in the protocol.\n9. Central nervous system metastases are allowed only for patients RAS-mutated and NF1-mutant melanoma cohorts (1) no leptomeningeal disease is present, (2) Intracranial disease is controlled by prior therapies, as evidenced by brain imaging 2 weeks post treatment indicating no new intracranial disease, (3) stable or decreasing dose of steroids is provided patient on ≤ 20mg of prednisone or it's equivalent daily.\n10. Any important medical illness or abnormal laboratory finding that would increase the risk of participating in the study (based on the investigator's judgment)\n11. Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n12. Has a known additional malignancy that is active and\u002For progressive requiring treatment; non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix, prior history of prostate cancer provided the patient is not undergoing active systemic treatment other than hormonal therapy and has documented PSA that is undetectable (\\\u003C0.2ng\u002FmL), prostate carcinoma in remission and did not receive systemic treatment, papillary thyroid cancer did not receive adjuvant radioactive iodine, Stage Rai stage 0 Chronic lymphocytic leukemia does not require systemic treatment, lymphoma, hairy-cell leukemia, or myelodysplasia is in complete remission and or other cancer for which the patient has been disease-free for at least two years.\n\n    Has a known additional malignancy that is active and\u002For progressive requiring treatment.\n13. Impaired GI function or GI disease that may significantly impair absorption (e.g., inflammatory bowel disease (IBD), malabsorption syndrome, small bowel resection, uncontrolled vomiting or diarrhea)\n14. Inability to swallow oral medications\n15. Patients with autoimmune diseases that require systemic corticosteroid treatment.","99 Years",{"count":361,"type":20},45,[56],"This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4\u002F6 inhibitor palbociclib.",[26,340,210],"2025-09-10",{"date":367,"type":36},"2025-09-11",{"date":369,"type":36},"2018-01-30",{"date":371,"type":20},"2026-11-24",{"name":373,"class":43},"UNC Lineberger Comprehensive Cancer Center",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":381,"targetDuration":4,"studyType":249,"phases":4,"briefSummary":383,"conditions":384,"keywords":387,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":404},"100577456","interest-of-preoperative-arteriography-to-identify-the-adamkiewicz-artery-before-surgery-for-basi-thoracic-neuroblastic-tumors-100577456","NCT06798532","Interest of Preoperative Arteriography to Identify the Adamkiewicz Artery Before Surgery for Basi-thoracic Neuroblastic Tumors","AKA-NBL","Inclusion Criteria:\n\n1. Patients undergoing surgery for a neuroblastic tumor (neuroblastoma, ganglioneuroblastoma, ganglioneuroma)\n2. Basithoracic location between T8 and L1\n3. With or without intraspinal component\n4. Treated in a pediatric surgery department in France\n5. Between 2005 and 2024\n6. Adult patients or holders of parental authority of minor patients informed and not opposed to the use of data for the study\n\nExclusion Criteria:\n\n1\\. Post-operative follow-up of less than 6 months",{"count":382,"type":20},150,"Neuroblastic tumors (NBTs) develop from neural crest cells that give rise to the sympathetic nervous system. They include neuroblastomas, ganglioneuroblastomas, and ganglioneuromas. They represent approximately 10% of solid tumors in children under 15 years of age. In 15 to 20% of cases, NBTs are located in the thoracic region. These paravertebral tumors have an extracanal component and some also have an intraspinal component (dumbbell tumors) that can cause spinal cord compression. Surgery for these tumors also exposes the patient to neurological complications. In the thorax, the basi-thoracic location (T9-T12) may be particularly at risk due to the presence of the artery of Adamkiewicz (AKA), which supplies blood to the spinal cord; damage to this artery can result in spinal cord ischemia. To avoid this scenario, some teams recommend performing spinal cord arteriography to identify AKA. However, many centers do not perform arteriography and do not report more postoperative complications.\n\nCurrently, there is no consensus on the indications for performing preoperative spinal arteriography in patients undergoing surgery for basi-thoracic NBT.\n\nThis study evaluates the practice in France of preoperative arteriography to identify the AKA among patients undergoing surgery for basi-thoracic neuroblastic tumors and analyzes the incidence of postoperative neurological complications in these patients.",[26,385,386],"Neuroblastic Tumors","Neuroblastoma",[388,389,390,391,392,393],"Neuroblastic tumors","Neuroblastomas","Ganglioneuroblastomas","Ganglioneuromas","Adamkiewicz Artery","Pediatric surgery","NOT_YET_RECRUITING","2025-09-05",{"date":397,"type":36},"2025-09-12",{"date":399,"type":20},"2025-10",{"date":401,"type":20},"2026-04",{"name":403,"class":43},"Assistance Publique - Hôpitaux de Paris",27,{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":415,"briefSummary":416,"conditions":417,"keywords":418,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":322},"100530985","phase-1-leu01101-safety-and-preliminary-efficacy-of-leu011-in-solid-tumours-100530985","NCT06193902","LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.","A Phase I\u002FIIa Open-label Dose Escalation Trial Evaluating the Safety and Preliminary Efficacy of LEU011 in Subjects With Relapsed\u002FRefractory Solid Tumours","AERIAL","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed solid tumour.\n2. 18 years or older at time of consent\n3. Relapsed\u002Frefractory solid tumour with no standard treatment options available or suitable (e.g. hypersensitivity reaction) and no curative approach possible.\n4. Tumour expression of NKG2DL protein. The minimum requirement is the presence of one or more ligands on 10% or more cells, encompassing tumour and\u002F or stroma.\n5. At least one target lesion measurable by RECIST v1.1 criteria on CT or MRI scanning\n6. Eastern Co-operative Oncology Performance Status of 0-1.\n7. Normal cardiac function as assessed by electrocardiography and echocardiography (ECHO. Left ventricular ejection fraction must be normal according to institutional values.\n8. Baseline oxygen saturation of at least 95%\n9. Haematology results must show:\n\n   * neutrophils \\>1.5 x 109\u002FL,\n   * platelets \\>100 x 109\u002FL,\n   * haemoglobin \\>90g\u002FL,\n   * INR \\\u003C1.3.\n   * Lymphocytes \\>0.4 x 109\u002FL\n10. Biochemistry results must show:\n\n    * creatinine clearance \\> 40 mL\u002Fmin\u002F1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology \\[CKD-EPI\\] equation); bilirubin \\\u003C1.25 times ULN;\n    * ALT\u002F AST \\\u003C2.5 times ULN (\\\u003C5 times ULN if liver metastases present);\n    * Albumin \\> 30g\u002FL\n11. Agree to use highly effective contraception (if applicable). Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test.\n12. Disease amenable to biopsy.\n13. Life expectancy of at least 6 months, in the investigator's opinion.\n14. Written informed consent prior to any trial procedure and registration.\n15. Subjects must agree to participate in an additional LTFU trial for up to 15 years after completion of this trial.\n\nExclusion Criteria:\n\n1. Subjects with HIV-1, HIV-2, HTLV-1, HTLV-2, active Hepatitis B, active Hepatitis C, or active Syphilis infection. Subjects without active Hepatitis B infection who are anti-core antibody positive can be considered for recruitment subject to suitability to receive nucleoside or nucleotide analogue prophylaxis.\n2. Subject must not have received any anti-cancer treatment within 28 days of lymphodepletion (prior to LEU011). This criterion applies to the following additional therapies: (i) systemic corticosteroids (\\> 20mg prednisolone\u002F day); (ii) any other systemic immunomodulatory agent (but see 11 below); (iii) radiotherapy; (iv) chemotherapy; (v) endocrine therapy or (vi) any investigational medicinal product.\n3. Regarding (iv) Chemotherapy: Interval is extended to 6 weeks in the case of nitrosoureas. This criterion does not apply to the use of lymphodepleting chemotherapy prior to treatment with LEU011.\n4. Prior LEU011 therapy. However, prior immune checkpoint blockade (e.g. anti-PD1, PD-L1 or CTLA-4) or immune agonist antibody therapy (e.g. anti-4-1BB, OX40, CD40 etc) does not preclude participation, but there must be a washout period of 30 days prior to treatment with LEU011.\n5. Concurrent use of warfarin anticoagulant therapy and other coumarins is not permissible. Other classes of anticoagulant can be given.\n6. The presence of major co-morbidity such as active major medical illness of the cardiovascular, respiratory or immune system that is likely to impair ability to undergo trial therapy, such as recent myocardial infarction, congestive cardiac failure, active gastrointestinal bleeding, active gastrointestinal ulceration, inflammatory bowel disease, ischaemic heart disease, peripheral arterial disease, pneumonitis, intestinal obstruction, sepsis or uncontrolled hypertension.\n7. Clinically active autoimmune disease e.g., coeliac disease (an abnormal TTG antibody test precludes recruitment) or interstitial lung disease. Sub-clinical or quiescent autoimmune disease does not exclude from participation (e.g. euthyroid patients on thyroxine replacement therapy or patients with type 1 diabetes on insulin therapy).\n8. Active infection that requires antimicrobial treatment.\n9. Subjects who, in the Investigator's judgement, are unlikely to complete or comply with all protocol required study visits or procedures.\n10. Hypersensitivity to any component of LEU011 (e.g. Albumin or DMSO allergy).\n11. Cyclophosphamide or fludarabine allergy or contraindication.\n12. Pregnancy.\n13. Breastfeeding.\n14. Subjects who have received a live vaccine four weeks or fewer before enrolment are ineligible for recruitment to the study. During treatment and for three months after treatment with fludarabine, administration of live vaccines is prohibited. None of the currently available covid 19 vaccines are considered to be live for this purpose since all are replication defective.",{"count":414,"type":20},17,[56,23],"This is a dose-escalation open-label Phase 1\u002F2a study. The purpose of this first-in-human study is to assess the safety and tolerability of LEU011 (autologous CAR T cells targeting NKG2D ligands) in patients with solid tumours.",[26],[419],"Solid Tumours, NKG2D Ligands, Adult","2025-09-02",{"date":422,"type":36},"2025-09-03",{"date":424,"type":36},"2023-11-13",{"date":426,"type":20},"2029-05",{"name":428,"class":77},"Leucid Bio",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":433,"targetDuration":4,"studyType":21,"phases":434,"briefSummary":274,"conditions":435,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":322},"100553320","phase-1-t-cell-receptor-gene-engineered-t-cell-therapy-targeting-kras-mutations-in-the-treatment-of-subjects-with-advanced-solid-tumor-100553320","NCT06484556",{"count":153,"type":20},[56],[26],"2025-07-27",{"date":438,"type":36},"2025-07-31",{"date":440,"type":36},"2024-06-19",{"date":442,"type":20},"2027-06-30",{"name":444,"class":43},"Tao Zhang",{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":21,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":100},"100591982","phase-1-a-study-of-parg-inhibitor-xnw29016-in-patients-with-advanced-solid-tumors-who-failed-standard-treatment-100591982","NCT06987500","A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of XNW29016 Tablets in Advanced Solid Tumors With Failed Standard Treatment","Inclusion Criteria:\n\n* Patients must have the ability to understand and sign an approved informed consent form (ICF).\n* Age at the time of consent ≥ 18 years;\n* Life expectancy of ≥ 3 months;\n* For prostate adenocarcinoma, at least one evaluable lesion by RECIST v1.1 and PCWG3 criteria; for other advanced solid tumor, at least one measurable lesion by RECIST v1.1 criteria.\n* Agree to provide tumor tissue samples that meet the testing requirements;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;\n* Phase Ia：Patients with advanced solid tumor confirmed by histological or cytological examination,who have failed standard of care therapy, or are unable to tolerate standard of care therapy, or unable to obtain\u002Funwilling to receive standard therapy.\n* Adequate hematologic and non-hematologic function during the screening.\n* Women of childbearing potential must have a negative result of serum pregnancy test at screening, and must agree to use a reliable and effective method of contraception during the study and for 6 months after the last dose of the study drug. Male patients must agree to take adequate contraceptive measures from the beginning of the study to at least 6 months after the last dose of the test drug, and prohibit sperm donation;\n* Ability to comply with all procedures of the clinical trial protocol.\n\nExclusion Criteria:\n\n* Any previous treatment with a PARG inhibitor.\n* Subjects known to be allergic to the study drug or its active ingredients or excipients;\n* Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose;\n* Subjects who participated in any other clinical trial of anti-tumor therapy within 28 days before the first dosing, and the last dose of other anti-tumor trial drug is within 28 days prior to the first administration of study drug in this trial;\n* Subjects who underwent major surgery within 4 weeks prior to the start of the study treatment, or who are scheduled to undergo a major surgery during the study period (procedures such as puncture or lymph node biopsy is allowed);\n* Subjects who have an allogeneic tissue\u002F solid organ transplantation;\n* Subjects who experienced toxicity events during previous anti-tumor treatment and the toxicity has not resolved (the toxicity events has not been graded as ≤ level 1 according to NCI-CTCAE 5.0). Other toxicities that the investigator does not think it will affect the safety assessment of the subject (such as hair loss, etc.) will be allowed;\n* Subjects who have a history of other malignancies within 3 years prior to enrollment and do not meet the criteria for clinical cure.\n* Central nervous system metastasis or disease;\n* Subjects who have impaired heart functions or clinically serious heart disease；\n* Have severe systemic active infection;\n* Have a history of tuberculosis within 1 year before enrollment, or had an active TB infection more than 1 year before but not received adequate anti-TB treatment;\n* Human immunodeficiency virus (HIV) positive, syphilis (Anti-TB) positive;\n* Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive, and HBV DNA ≥ 200 IU\u002FmL or ≥ 103 copies\u002FmL) or acute or chronic active hepatitis C (HCV antibody positive and positive for HCV RNA test);\n* Known impaired gastrointestinal (GI) function or GI diseases that may significantly affect the absorption or metabolism of oral drugs; abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the first administration;\n* Subjects taking known moderate or strong inducers and inhibitors of CYP3A within 14 days before the first administration;\n* Active autoimmune and inflammatory diseases；\n* Women who are pregnant or breastfeeding；\n* Subjects who are considered unsuitable for the study judged by the investigator.",{"count":453,"type":20},132,[56,23],"The purpose of this study is to characterize the safety, tolerability, and efficacy of XNW29016 in participants with advanced solid tumors .",[26],"2025-06-03",{"date":459,"type":36},"2025-06-06",{"date":461,"type":36},"2025-04-11",{"date":463,"type":20},"2027-08-16",{"name":465,"class":77},"Evopoint Biosciences Inc.",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":473,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":476,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":490,"locationsCount":322},"100589580","phase-1-nw-301-tcr-t-in-patients-with-advanced-solid-tumor-100589580","NCT06956261","NW-301 TCR-T in Patients With Advanced Solid Tumor","Open-label, Single-arm, Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Autologous TCR-T Cell Therapy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Aged 18 to 75 years, male or female; Subjects with pathologically confirmed Pancreatic Cancer and Colorectal Cancer and Lung Adenocarcinoma Cancer and have been failed to stand of care systemic treatment or have been untolerated to stand of care systemic treatment; HLA-A\\*11:01 positive Tumor tissue samples. sample was positive for KRAS G12V or G12D mutation; Estimated life expectancy \\> 12 weeks; According to the RECIST 1.1, there is at least one measurable tumor lesion； ECOG physical status score 0 \\~ 1; Sufficient venous access for mononuclear cell collection (abbreviation: apheresis) Subjects should have adequate organ functions before screening and pre-treatment (at baseline).\n\nFemale subjects of childbearing age must undergo a serum pregnancy test at screening and prior to preconditioning and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment. The methods that can be used are: bilateral tubal ligation \u002F bilateral salpingectomy or bilateral tubal occlusion; or approved oral, injection or hormone-imparting contraceptive methods; or barrier contraceptive method: containing spermicidal foam \u002F Gel\u002Ffilm\u002Fcream\u002Fsuppository condom or occlusive cap (diaphragm or cervix\u002Fcap); Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy, for example, a condom containing a spermicidal foam\u002Fgel\u002Ffilm\u002Fpaste\u002Fsuppository, or use a contraceptive method for their spouse (see article 9 of the inclusion criteria). Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last study treatment infusion； Subject participates in this clinical trial and sign Informed Consent Form voluntarily.\n\nExclusion Criteria:\n\n* Received the following therapy\u002Ftreatment : Cytotoxic chemotherapy within 1 week prior to leukapheresis or lymphodepleting chemotherapy , Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors) within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Corticosteroids within 2 weeks prior to leukapheresis and within 72 hrs prior to lymphodepleting chemotherapy Immunosuppressive drugs within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Tyrosine kinase inhibitor (TKI) (e.g. pazopanib) within 1 week prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy KRAS G12V mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12V mutation cohort KRAS G12D mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12D mutation cohort Anti-cancer Vaccine, Gene therapy using an integrating vector , Investigational treatment or interventional clinical trial prior to leukapheresis and lymphodepleting chemotherapy Major surgery prior to leukapheresis History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.\n\nHistory of autoimmune or immune mediated disease Symptomatic CNS metastases including leptomeningeal disease. Other prior malignancy that is not considered by the Investigator to be in complete remission Clinically significant cardiovascular disease Uncontrolled intercurrent illness Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus Pregnant or breastfeeding","70 Years",{"count":475,"type":20},44,[56],"An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V\u002FG12D mutation T-cell Receptor T cell in advanced solid tumor",[26],[480,481,482,483],"TCR-T","KRAS","G12V","G12D","2025-04-30",{"date":486,"type":36},"2025-05-04",{"date":488,"type":20},"2025-05-10",{"date":173,"type":20},{"name":491,"class":43},"Peking University",{"id":493,"slug":494,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":16,"minAge":500,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":21,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":44},"100586127","phase-1-ad1208-in-subjects-with-any-progressive-locally-advanced-or-metastatic-solid-tumors-100586127","NCT06911333","AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa Trial of AD1208, a Cell Cycle Inhibitor\u002FMASTL Inhibitor, as a Single Agent or a Combination in Subjects With Any Progressive, Locally Advanced(Unresectable) or Metastatic Solid Tumors","AD1208","Inclusion Criteria:\n\n* Male or female subjects ≥19 years of age\n* Willing to consent to participate in study and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\n* Histologically and\u002For cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, standard therapy does not exist or is not considered appropriate.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Life expectancy of at least 12 weeks\n* Subjects with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory test within 2 weeks prior to the first administration of IP.\n* Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months following the last dose of IP.\n* Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time the partner is breastfeeding throughout the study period and for 6 months after the final administration of IP.\n\nExclusion Criteria:\n\n* Untreated active brain metastases.\n* has leptomeningeal disease.\n* unrecovered \\> Grade 1 from the adverse event of prior therapy except for alopecia.\n* has an active autoimmune disease requiring systemic treatment within the past 2 years.\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.\n* Subject has received the following treatment;\n\n  * prior anticancer monoclonal antibody treatment or investigational therapy\n  * prior any chemotherapy\n  * prior radiotherapy\n  * Major surgery\n* Clinically significant (i.e., active) cardiovascular disease\n* known positive of human immunodeficiency virus (HIV) infection.\n* Active hepatitis B or C subjects.\n* known allergic reaction for active ingredients or inactive ingredients such as excipients of Investigational product.\n* Live vaccine administered against infectious disease.\n* Gastrointestinal (GI) track disease causing the inability to take oral medication, malabsorption syndrome or uncontrolled inflammatory GI disease.\n* having psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* women with a positive pregnancy test at screening test.\n* women who are breast feeding.\n* subject has any condition because of which, in the opinion of the investigator, the participation would not be in the best interest of the subject.","19 Years",{"count":502,"type":20},36,[56,23],"The goal of this clinical trial is to evaluate the safety and tolerability of AD1208 to determine the maximum tolerated dose(MTD) or maximumly administered dose(MAD) in any progressive, locally advanced (unresectable) or metastatic solid tumors. The main questions it aims to answer are:\n\n* Which dosage of AD1208 is safe and tolerable for participants?\n* What medical problems do participants have when taking AD1208?\n\nParticipants will:\n\n* Take drug AD1208 every day up to 1 cycle at the least.\n* Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards.\n* Keep a diary of any adverse events and administrated drug",[60,26,506,63,507,508,509],"Solid Tumor","Solid Tumor Cancer","Solid Tumors Refractory to Standard Therapy","Solid Tumor in Advanced Stage","2025-03-28",{"date":512,"type":36},"2025-04-04",{"date":514,"type":36},"2025-03-11",{"date":516,"type":20},"2030-02-20",{"name":518,"class":77},"Avelos Therapeutics Inc.",{"id":520,"slug":521,"hasResults":11,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":21,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":542},"100523026","phase-1-a-study-of-or502-a-monoclonal-antibody-targeting-lilrb2-alone-and-in-combination-with-anticancer-agents-100523026","NCT06090266","A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents","A Phase 1\u002F2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies","Inclusion Criteria:\n\n1. Informed consent signed by the subject prior to conducting study-specific procedures.\n2. Male or female subjects ≥ 18 years of age.\n3. Histological diagnosis as follows:\n\n   1. Parts A and B (Cohorts A1, A2, and B1): subjects must have a histological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy with curative intent.\n   2. Part B (Expansion Cohorts B2-B3): subjects must have a histological diagnosis of the relevant tumor type (CSCC or PROC) with advanced\u002Fmetastatic disease not amenable to local therapy with curative intent.\n4. Prior therapies:\n\n   a. Part A (dose-escalation) and Cohort B1 (monotherapy expansion) i. Subjects must have experienced progressive disease (PD) on an established standard systemic anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds. Subjects must have no available proven curative or life prolonging therapies.\n\n   b. Cohorts B4 and B5 (mini-expansion cohorts) i. Subjects must have received a PD-(L)1 inhibitor-based therapy, either alone or in combination with other anti-cancer agents, for at least 12 weeks. If subjects have received other lines of immunotherapy, including PD-(L)1-based therapy, they must have demonstrated clinical benefit on each prior immunotherapy. Subjects may also have received additional anti-cancer therapies after failure of a PD-(L)1 inhibitor, but 2nd line subjects are preferred.\n\n   c. Cohorts B2 and B3 (dose-expansion) i. Cohort B2 subjects (CSCC) must have received a PD-(L)1 inhibitor. Subjects may not have received an additional immunotherapy.\n\n   ii. Cohort B3 subjects (PROC) must have received platinum-based therapy and experienced disease progression on or within 6 months of completion of such therapy. Subjects may have received prior anti-PD-1 therapy. Subjects may have received additional therapies after failure of platinum-based therapy.\n5. Subjects must have measurable disease per RECIST v1.1.\n6. People of childbearing potential, if not postmenopausal (defined as no menses for at least 12 continuous months prior to study entry) or surgically sterile, must be willing to practice at least one of the highly effective methods of birth control described in Section 4.3 for at least a menstrual cycle (or partner's menstrual cycle, for male subjects) before and for 4 months after study medication administration.\n7. Resolution of prior clinically significant therapy-related AEs (excluding alopecia and ≤ Grade 2 peripheral neuropathy) to ≤ Grade 1 per NCI-CTCAE version 5.0, and no treatment for these AEs for at least 2 weeks prior to the time of enrollment. Electrolyte and hormonal supplementation may be used to treat these AEs provided the subject is stable on these supplements.\n8. Minimum of 2 weeks since the last dose of other hormone therapy and 3 weeks since the last dose of other systemic cancer therapy or radiotherapy (\\> 4 weeks in case of nitrosoureas or radio-immuno conjugate therapy). Adjuvant hormonal therapy (e.g., tamoxifen) is allowed provided the original tumor diagnosis was more than 3 years before the first dose of study medication. Subjects with prostate cancer on stable doses of anti-hormone treatment may remain on therapy for this trial.\n9. Subjects must have adequate organ function.\n10. Biopsy specimens:\n\n    1. All subjects must be able to supply an archival tumor tissue specimen. If an archival specimen is not available, subjects may remain eligible with approval of the medical monitor.\n    2. Subjects in Cohort B1 must consent to pre- and on-treatment biopsies. Tissue obtained for the biopsy must not be previously irradiated. No systemic anti-neoplastic therapy may be received by the subject between the time of the biopsy and the first administration of study medication.\n    3. Subjects in all other cohorts will be asked to consent to pre- and on-treatment biopsies for biomarker analysis of the acquired tissue. These biopsies are optional and not required for study participation. Tissue obtained for the biopsy must not be previously irradiated. No systemic anti-neoplastic therapy may be received by the subject between the time of the biopsy and the first administration of study medication.\n11. Subject is able and willing to comply with the protocol and the restrictions and assessments therein.\n12. As required by local regulations or law, subjects must fulfill the obligation of affiliation or beneficiary of a social security or similar scheme.\n\nExclusion Criteria:\n\n1. Subject previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).\n2. Life expectancy \\\u003C 12 weeks.\n3. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \\> 2.\n4. Prior organ or stem cell transplant.\n5. Subjects with symptomatic ascites or pleural effusion. Subjects who are clinically stable for at least 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) are eligible.\n6. Subject has a known active central nervous system (CNS) primary tumor or metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg\u002Fday for at least 15 days prior to first dose of study medication. Subjects who have symptoms consistent with CNS metastasis must have a negative magnetic resonance imaging (MRI) scan during the screening period.\n7. Subject has a known history of a hematologic malignancy, malignant primary brain tumor, or another malignant primary solid tumor (other than that under study), unless the subject has undergone potentially curative therapy with no evidence of recurrent disease for at least 3 years before the start of treatment.\n\n   1. Subjects with a known history of AJCC Stage 1 cancer that has undergone potentially curative therapy with no evidence of recurrent disease for at least 1 year before the start of treatment may be eligible at the Investigator's discretion after consultation with the Sponsor.\n   2. Subjects who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers at any time before the start of treatment, and have no evidence of recurrent disease, are eligible.\n8. Recent or ongoing serious infection including the following:\n\n   1. Any uncontrolled Grade 3 or higher (per NCI-CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of OR502. Routine antimicrobial prophylaxis is allowed.\n   2. Uncontrolled infection with human immunodeficiency virus (HIV). Subjects on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.\n   3. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for hepatitis B indicating acute or chronic infection. Subjects who are or have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for hepatitis B at screening is not required.\n   4. Known active hepatitis C as determined by positive serology and confirmed by polymerase chain reaction (PCR). Subjects on or having received anti-retroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for hepatitis C at screening is not required.\n   5. Known active or latent tuberculosis (testing at screening is not required).\n9. Autoimmune disease or inflammatory condition requiring systemic anti-inflammatory therapy with exceptions as noted in Exclusion Criterion 10. Subjects on hormone replacement therapy for autoimmune-induced endocrinopathies are eligible.\n10. Use of systemic corticosteroids within 15 days or other immunosuppressive drugs within 30 days prior to start of the study, with the exception of corticosteroids as replacement therapy up to an equivalent of prednisone 10 mg\u002Fday, which are allowed.\n11. QTc interval ≥ 470 msec by electrocardiogram (ECG).\n12. Subject has received an investigational product or been treated with an investigational device within 30 days prior to first administration of study medication.\n13. Subject has received a live vaccine within 30 days prior to first administration of study medication.\n14. For Cohorts A2, B1, B2, and B3 only:\n\n    1. Known hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling.\n    2. Interstitial lung disease.\n    3. Prior pneumonitis requiring systemic corticosteroid therapy.\n    4. Receiving immunosuppressive therapy, with exceptions as noted in Exclusion Criterion 10.\n    5. A history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (\\> 10 mg\u002Fday prednisone or equivalent) for more than 12 weeks.\n15. Concurrent therapy with anti-cancer or anti-neoplastic drugs, with the exception of adjuvant hormonal therapy, which is allowed as outlined in Inclusion Criterion 8.\n16. History or clinical evidence of any surgical or medical condition that the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, e.g., rapidly progressive or uncontrolled disease involving a major organ system-vascular, cardiac, pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or an immunodeficiency, or clinically significant active psychiatric or abuse disorders.\n17. Subjects who, at the time of signing informed consent, had a recent history (within the last year) of chronic substance abuse.\n18. Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.\n19. Vulnerable persons: subjects under judicial safeguard, subjects deprived of their liberty by judicial or administrative decision, subjects under psychiatric care without their consent, subjects admitted to a health or social institution for purposes other than research, adults subject to a measure of legal protection (guardianship or curatorship), and subjects unable to express their consent.",{"count":185,"type":20},[56,23],"This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR502 administered as a monotherapy and in combination with cemiplimab in subjects with advanced solid tumors.",[59,26,530,200,144,531,532],"Malignant Neoplasm","Cutaneous Melanoma","Non-small Cell Lung Cancer","2025-01-03",{"date":535,"type":36},"2025-01-07",{"date":537,"type":36},"2023-10-24",{"date":539,"type":20},"2027-02-01",{"name":541,"class":77},"OncoResponse, Inc.",4,{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":21,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":394,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":100},"100528608","pet-imaging-of-68ga-nota-h006-in-malignancy-100528608","NCT06162988","PET Imaging of 68Ga-NOTA-H006 in Malignancy","A Study to Evaluate 5T4 Expression in Malignant Tumors Using 68Ga-NOTA-H006","Inclusion Criteria:\n\n* Pancreatic cancer clinical trial study subjects must meet all of the following criteria:\n\n  1. Age between 18 and 65 years old.\n  2. Pancreatic occupancy is found on imaging and combined with clinical judgment as a patient with pancreatic cancer.\n  3. Written informed consent signed by the subject or his\u002Fher legal guardian or caregiver.\n  4. Willingness and ability to cooperate with all programs of the study.\n\nLung cancer clinical trial study subjects must meet all of the following criteria:\n\n1. Be between the ages of 18 and 65 years old.\n2. Patients with CT findings of suspicious space on the lungs with a diameter of more than 1cm who have not undergone surgery.\n3. Written informed consent must be signed by the subject or his\u002Fher legal guardian or caregiver.\n4. Willingness and ability to cooperate with all programs of the study.\n\nBowel cancer clinical trial study subjects must meet all of the following criteria:\n\n1. Be between the ages of 18 and 65.\n2. Have a clear histologic or pathologic diagnosis of colorectal cancer.\n3. Written informed consent signed by the subject or legal guardian or caregiver.\n4. Willingness and ability to cooperate with all programs of this study.\n\nExclusion Criteria:\n\n1. Severe hepatic or renal insufficiency;\n2. Targeted therapy prior to radiotherapy or PET\u002FCT scan. 5T4 expression in existing lesions assessed by immunohistochemistry using antibody clones.\n3. History of serious surgery in the last month.\n4. Those who have participated in other clinical trials during the same period.","65 Years",{"count":552,"type":20},15,[88],"5T4, also known as trophoblast glycoprotein, is an oncofoetal antigen expressing in fetal development and cancer but rarely in adult. The high expression of 5T4 in malignancy was found be associated with poor clinical outcomes in ovarian, gastric and colorectal cancers. Several antibody drug conjugates are currently under development for cancer therapy in preclinic and clinic stages.\n\nPreviously, investigators engineered a 5T4-specific biomolecule with nanomolar binding affinity. Radiolabeling with gallium-68 resulted in 68Ga-NOTA-H006 which showed 5T4 expression in a variety of xenograft models. Thus, the aims of current study are to evaluate the distribution and dosimetry of this novel tracer, and to explore the diagnostic values of 68Ga-NOTA-H006 in malignant tumors.",[26],"2023-12-06",{"date":558,"type":36},"2023-12-08",{"date":560,"type":20},"2023-12",{"date":562,"type":20},"2028-12",{"name":564,"class":43},"YiHui Guan",{"id":566,"slug":567,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":571,"enrollmentInfo":572,"targetDuration":4,"studyType":21,"phases":574,"briefSummary":575,"conditions":576,"keywords":579,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":100},"100394446","comparison-of-fdg-and-fapi-in-patients-with-various-types-of-cancer-100394446","NCT04416165","Comparison of FDG and FAPI in Patients With Various Types of Cancer","Inclusion Criteria:\n\n* (i) adult patients (aged 18 years or order); (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET\u002FCT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.","90 Years",{"count":573,"type":20},3000,[88],"To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET\u002FCT.",[26,577,578],"Positron-Emission Tomography","Metastasis",[577,26,580,578],"Diagnosis","2023-08-06",{"date":583,"type":36},"2023-08-08",{"date":585,"type":36},"2019-10-20",{"date":587,"type":20},"2027-12-30",{"name":589,"class":43},"The First Affiliated Hospital of Xiamen University",{"id":591,"slug":592,"hasResults":11,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":249,"phases":4,"briefSummary":599,"conditions":600,"keywords":604,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":542},"100499576","biomarkers-of-renal-cancer-100499576","NCT05785052","Biomarkers of Renal Cancer","BRC","Inclusion Criteria for renal-mass patients:\n\n* Men and women over 18 years of age\n* Diagnosis of first episode of renal mass\n* Caucasian race\n* Signed, informed consent\n\nExclusion Criteria renal-mass patients:\n\n* Any other concomitant cancer or history of active cancer in the last 5 years\n* Oncological genetic syndrome\n* Previous history of renal tumour\n* Urothelial cancer\n* End-stage renal disease on hemodialysis\n* Bilateral renal cell carcinoma\n\nInclusion Criteria for control subjects:\n\n* Men and women over 18 years of age\n* Caucasian race\n* Living kidney donor or patient with urological functional diseases (e.g. kidney stones, benign prostate hypertrophy, etc..)\n* Signed, informed consent\n\nExclusion criteria for control subjects:\n\n* History of active cancer in the last 5 years\n* Oncological genetic syndrome\n* End-stage renal disease on hemodialysis or peritoneal dialysis",{"count":598,"type":20},1000,"The aim of the present study is the identification, in liquid biopsies, of a new molecular panel able to discriminate renal cancer patients from controls, to discriminate patients with a malignant lesion from those with a benign mass, to determine aggressiveness of RCC, and to differentiate the most common histological subtypes of RCC (clear cell, papillary 1, papillary 2, and chromophobe).\n\nThis new molecular panel will be combined with clinical parameters to provide a screening test and to improve the accuracy and specificity of diagnosis, prognosis, and histological classification of renal cancer.",[601,26,602,603],"Renal Cell Carcinoma","Oncocytoma","Angiomyolipoma",[605,606,601,607,67],"Biomarkers","Urology","Molecular Biomarkers","2023-03-14",{"date":610,"type":36},"2023-03-27",{"date":612,"type":36},"2019-06-11",{"date":614,"type":20},"2026-06",{"name":616,"class":77},"Biorek S.R.L."]