[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancers":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100615394","phase-1-safety-and-pharmacokinetics-of-nm6603-in-chinese-patients-with-advanced-solid-tumors-100615394",false,"NCT07292038","Safety and Pharmacokinetics of NM6603 in Chinese Patients With Advanced Solid Tumors","A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NM6603 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Advanced solid tumors (primarily advanced colorectal cancer or triple-negative breast cancer) confirmed by histology or cytology\n* Prior adequate standard therapy with documented progression or intolerance, or lack of available standard therapy options, or contraindications to standard therapy\n* At least one evaluable tumor lesion per RECIST version 1.1\n* Age 18 to 75 years at the time of informed consent\n* Body weight 45 kg or greater for men and 40 kg or greater for women\n* ECOG performance status 0 or 1\n* Expected survival time greater than 12 weeks\n* Adequate organ and bone marrow function as defined below:\n\n  * Absolute neutrophil count 1500 per mm3 or greater\n  * Platelet count 100000 per mm3 or greater with no transfusion or growth factor use within 14 days before first dose\n  * Hemoglobin 9.0 g\u002FdL or greater with no transfusion or stimulating factors within 14 days before first dose\n  * Total bilirubin 1.5 times upper limit of normal (ULN) or less (patients with Gilbert syndrome allowed)\n  * AST and ALT 2.5 times ULN or less without liver metastasis, or 5 times ULN or less with liver metastasis\n  * Creatinine clearance 60 mL\u002Fmin or greater (Cockcroft-Gault formula)\n  * INR 1.5 times ULN or less and APTT 1.5 times ULN or less\n* Male subjects and female subjects of childbearing potential agree to use effective contraception from signing consent until 6 months after last dose; men must not donate sperm; women of childbearing potential require a negative pregnancy test within 7 days prior to first dose\n* Able and willing to comply with study visits, procedures, and provide written informed consent\n\nExclusion Criteria:\n\n* Known hypersensitivity to NM6603 or its components\n* Prior treatment with a drug targeting the same mechanism of action or molecular target\n* Participation in another drug or device clinical trial within 4 weeks before first dose\n* Major surgery within 4 weeks before first dose or planned surgery during the study\n* Chemotherapy, biologic therapy, macromolecular targeted therapy, or radiotherapy within 4 weeks before first dose\n* Oral fluoropyrimidines or other small molecule targeted agents received within 2 weeks or 5 half-lives before first dose (whichever is longer)\n* Use of traditional Chinese medicine or herbal products with antitumor activity within 2 weeks before first dose\n* Use of medications known to prolong QT interval or strong inhibitors or inducers of CYP1A2, CYP2A6, or CYP3A4 within 7 days before first dose, or requirement for continued use\n* Systemic corticosteroids or immunosuppressive drugs at doses greater than 10 mg\u002Fday prednisone or equivalent within 4 weeks before first dose (physiologic replacement and topical\u002Finhaled forms allowed)\n* History of another malignancy within 5 years except for curatively treated carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ\n* Active central nervous system metastases, including symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or unstable brain metastasis\n* Treated brain metastases allowed if stable for 4 weeks or longer, no neurologic symptoms, and not receiving systemic corticosteroids above replacement dose for 4 weeks\n* Untreated asymptomatic brain metastases 1.5 cm or smaller allowed if not requiring corticosteroids\n* Uncontrolled disease including:\n\n  * Active infection\n  * Acute coronary syndrome, symptomatic heart failure (NYHA class 2 or greater), cerebrovascular accident, transient ischemic attack, stroke, deep vein thrombosis, pulmonary embolism, aneurysm, arterial dissection, or other grade 3 or higher cardiovascular or cerebrovascular events within 6 months\n  * Left ventricular ejection fraction less than 50 percent, uncontrolled hypertension (systolic over 160 mmHg or diastolic over 100 mmHg), uncontrolled hyperglycemia, ventricular arrhythmias requiring intervention, second or third degree AV block, congenital long QT syndrome, QTcF greater than 450 ms\n  * Active peptic ulcer, gastritis, or bleeding disorder\n  * Risk factors for pancreatitis including history of pancreatitis, uncontrolled hyperlipidemia, excessive alcohol use, uncontrolled diabetes, gallbladder disease, or medications associated with elevated triglycerides or pancreatic toxicity\n  * Psychiatric or social conditions that may affect study compliance or ability to provide informed consent\n* Family history of long QT syndrome or unexplained sudden death before age 40 in a first-degree relative\n* Inability to swallow oral medication or gastrointestinal disease or major GI surgery likely to impair drug absorption, metabolism, or excretion\n* Known alcohol or substance dependence\n* Active syphilis; positive HIV antibody; positive HCV antibody with detectable HCV RNA; active hepatitis B infection (HBsAg positive with HBV DNA 1000 IU\u002FmL or greater)\n* Not recovered to grade 1 or less from prior therapy toxicity (NCI CTCAE v5.0), except for alopecia, irreversible grade 1 fatigue, or clinically insignificant lab abnormalities such as lymphocyte count decrease\n* Pregnant or breastfeeding women or women planning pregnancy during the study\n* Any condition that, in the investigator's judgment, makes the subject unsuitable or may affect compliance","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is to assess the MTD and PK of NM6603 in adult patients with advanced solid tumors.",[27],"Cancers",[29],"advanced solid tumors","RECRUITING","2026-01-12",{"date":33,"type":34},"2026-01-14","ACTUAL",{"date":36,"type":34},"2025-12-18",{"date":38,"type":21},"2026-11",{"name":40,"class":41},"NucMito Pharmaceuticals Co. Ltd.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":4,"maxAge":50,"enrollmentInfo":51,"targetDuration":53,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100462288","ovarian-tissue-cryopreservation-in-pre-pubertal-otc-pre-pubertal-100462288","NCT05299710","Ovarian Tissue Cryopreservation in Pre-Pubertal (OTC-Pre Pubertal)","Ovarian Tissue Freezing for Fertility Preservation in Pre-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen","Inclusion Criteria:\n\n* Pre- Pubertal Individual\n* Will undergo imminent surgery, chemotherapy or radiation therapy that has implications on future fertility and reproductive hormone potential: any health condition or malignancy that requires removal of all or part of one or both ovaries, whole abdomen or pelvic irradiation ≥10Gy in post-pubertal girls or ≥15Gy in pre-pubertal girls total body irradiation, and alkylating-intensive chemotherapy:\n* cyclophosphamide cumulative dose ≥7.5 g\u002Fm2\n* any treatment regimen containing procarbazine\n* busulfan cumulative dose \\>600 mg\u002Fm2\n* alkylating chemotherapy conditioning prior to stem cell transplantation combination of any alkylating agent with total body irradiation or whole abdomen or pelvic radiation cranial radiation ≥30 Gy summed alkylating agent dose score ≥3 (Green et al., 2009) cyclophosphamide equivalent dose (CED) ≥ 4,000 mg\u002Fm2 (Green et al., 2014)\n\nExclusion Criteria:\n\n* Patients with no anticipated oncologic therapies\n* Post-pubertal individuals\n* Pregnant children\n* Children with one ovary\n* Children deemed high risk for perioperative complications\n* Patients unable to provide consent\u002Fassent (i.e. significant psychiatric problems\u002Fcognitive delay)","FEMALE","11 Years",{"count":52,"type":21},250,"10 Years","OBSERVATIONAL","The purpose of this study is to safely remove ovarian tissue in pre-pubertal pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.",[27],[58],"OTC, fertility","2024-11-14",{"date":61,"type":34},"2024-11-18",{"date":63,"type":34},"2018-05-29",{"date":65,"type":21},"2035-01",{"name":67,"class":68},"Erin Rowell","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":82,"conditions":83,"keywords":92,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100548075","risk-and-clinical-consequences-of-low-count-monoclonal-b-cell-lymphocytosis-lc-mbl-100548075","NCT06416267","Risk and Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)","Immune Biomarkers, Genetic Risk, and the Clinical Consequences of Low Count Monoclonal B-cell Lymphocytosis (LC MBL)","MBL RiskConseq","Inclusion Criteria:\n\n* Individuals over the age pf 40\n\nExclusion Criteria:\n\n* Individuals with lymphoproliferative disorder",true,"40 Years",{"count":81,"type":21},1500,"The aim of this proposal is to identify immune biomarkers, genetic risk, and the clinical consequences of low count monoclonal B-cell lymphocytosis (LC MBL), a common premalignant condition affecting up to 17% of European adults age\\>40. LC MBL is a precursor to chronic lymphocytic leukemia (CLL), characterized by a circulating population of clonal B-cells. It is relatively understudied, despite emerging evidence of clinical consequences such as increased risk for life-threatening infections and lymphoid malignancies. Studies reported that male sex, age, family history of CLL, and CLL-susceptibility genetic loci were associated with LC MBL risk. These findings were reported in European ancestry individuals and have not been generalized to other thnicities. This study will provide this missing knowledge using a unique multi-ethnic Israeli population of Jews and Arabs that have one of the highest and lowest age-standardized incidence rates of CLL in the world, respectively, and characterized with different genetic backgrounds.",[84,85,86,27,87,88,89,90,91],"Monoclonal B-Cell Lymphocytosis","Chronic Lymphocytic Leukemia","Infections","Cardiovascular Diseases","Alzheimer Disease","Dementia","Autoimmune Diseases","Parkinson Disease",[93,94,95,86,27,96],"Monoclonal B cell Lymphocytosis","Genetic Risk","Outcomes","CLL","NOT_YET_RECRUITING","2024-05-10",{"date":100,"type":34},"2024-05-16",{"date":102,"type":21},"2024-08",{"date":104,"type":21},"2040-12",{"name":106,"class":68},"University of Haifa"]