[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NovaRock Biotherapeutics, Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100506710","phase-1-a-study-of-nbl-020-injection-in-subjects-with-advanced-malignant-tumors-100506710",false,"NCT05877924","A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Activity of NBL-020 Injection in Subjects With Advanced Malignant Tumors.","Inclusion Criteria:\n\n1. Those who are 18 years old or older (based on the date of signing the informed consent form) and voluntarily sign the informed consent form;\n2. For malignant tumors confirmed by histology or cytology, only solid tumor subjects were included in dose escalation study. In addition to solid tumors, additional skin T-cell lymphoma subjects could be considered in dose expansion study;\n3. Must be willing to provide tumor tissue samples that can meet the requirements of biomarker testing (fresh biopsy tissue is preferred; if fresh tissue cannot be provided, tumor tissue samples within 2 years can be provided), and tumor samples will be tested by the central laboratory. If tumor tissue does not meet the testing requirements, additional biopsy may be required;\n4. If the standard treatment fails or toxicity is intolerable, or there is no standard treatment, the enrolled subjects must fully recover from previous treatment, with an AE level of 0-1 (except for alopecia, pigmentation, or other toxicity that the researcher believes is not a safety risk to the subjects);\n5. For subjects with solid tumor, there is at least one measurable lesion that meets the RECIST 1.1 standard at the baseline (the measurable lesion area has not received radiotherapy in the past, or there is evidence that the lesion has unequivocal progressed after radiotherapy);\n6. ECOG PS score 0-1 points;\n7. Expected survival time ≥ 3 months (12 weeks);\n8. Good organ function (no blood transfusion or growth factor support treatment received within 2 weeks before blood collection for relevant examinations), including:\n\n   1. Absolute value of neutrophils (ANC) ≥ 1.5 × 10\\^9\u002FL；\n   2. Hemoglobin (Hb) ≥ 90 g\u002FL;\n   3. Platelets ≥ 100 × 10\\^9 \u002FL;\n   4. Creatinine ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥ 50 mL\u002Fmin (Cockcroft Fault formula);\n   5. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome）;\n   6. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver metastasis);\n   7. Coagulation function: activated partial thromboplastin time(APTT), international standardized ratio (INR) ≤ 1.5 × ULN.\n\n   Note: If the subject does not meet the requirements during screening, a re-examination is allowed.\n9. The subjects must agree to take effective contraceptive measures from the signing of the informed consent form until 6 months after the last administration. Women of childbearing age tested negative for serum pregnancy within 7 days before the first dose of the investigational drug.\n\nExclusion Criteria:\n\n1. Subjects with a history of severe allergies to monoclonal antibodies;\n2. Active pia mater lesions or uncontrolled brain metastases exist. Subjects with suspected or confirmed brain metastasis can be enrolled as long as they are asymptomatic and do not require treatment (such as radiotherapy, surgery, or corticosteroid therapy) to control the symptoms of brain metastasis. For subjects with brain metastasis requiring treatment, their symptoms remain stable (without hormone maintenance treatment, without symptoms of brain metastasis) for 2 weeks after treatment, and they can be enrolled.\n3. Subjects with active autoimmune diseases or a history of autoimmune diseases, but with the following diseases are allowed to be included in the study: well controlled type I diabetes, well controlled hypothyroidism only requiring hormone replacement treatment, skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or subjects who are expected to have no relapse under the condition of no external trigger factors;\n4. Having a history of primary immunodeficiency, a history of allogeneic organ transplantation, or a history of allogeneic hematopoietic stem cell transplantation;\n5. Chronic hepatitis B (HBsAg and\u002For HBcAb positive but HBV DNA\\\u003C2000 IU\u002FmL can be included), chronic hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive;\n6. The toxicity of previous anti-tumor treatments has not returned to ≤ Grade 1 (except for alopecia, pigmentation, or other toxicity that the researchers believe is not a safety risk to the subjects);\n7. Have a history of serious cardiovascular disease, including but not limited to:\n\n   1. Serious cardiac rhythm or conduction abnormalities, including but not limited to ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, within 6 months prior to the first dose of the investigational drug;\n   2. Have a history of myocardial infarction, unstable angina, angioplasty, or coronary artery bypass surgery within 6 months before the first dose of the experimental drug;\n   3. Heart failure, classified as Grade Ш or above by the New York Heart Association (NYHA);\n   4. Subjects with prolonged QT\u002FQTc interval in the screening period electrocardiogram);\n   5. During the screening, echocardiography showed left ventricular ejection fraction (LVEF)\\\u003C50%;\n   6. Poor control of hypertension (screening period systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg);\n8. Uncontrollable serous cavity effusion that requires frequent drainage or medical intervention (such as pleural effusion, abdominal effusion, pericardial effusion, etc., which requires additional intervention within 2 weeks after the intervention, excluding exfoliative cytology testing of the exudate) within 7 days before the first dose of the experimental drug;\n9. Severe or active infections (including tuberculosis infections) that require systemic antibacterial, antifungal, or antiviral treatment within 14 days before the first use of the experimental drug, except for subjects with viral hepatitis receiving antiviral treatment;\n10. Received any anti-tumor treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) and any clinical research treatment within 4 weeks or 5 half-lives before the first administration (whichever is shorter);\n11. Have a history of (non-infectious) pneumonia\u002Finterstitial lung disease requiring steroid treatment, or currently have (non-infectious) pneumonia\u002Finterstitial lung disease requiring steroid treatment.\n12. Subjects are required to receive systemic corticosteroids (\\>10 mg daily prednisone or equivalent) or immunosuppressive therapy within 14 days before the first dose. Inhalation or local application of corticosteroids, adrenal hormone replacement therapy, and short-term (≤ 7 days) use of corticosteroids to prevent contrast agent allergies are allowed.\n13. History of immune related adverse events (immune-related AE) ≥ Grade 3 (CTCAE 5.0) after receiving immunotherapy;\n14. Previously received targeted TNFR2 treatment;\n15. Those who have undergone major surgery within 4 weeks before the first administration and have not yet fully recovered, or plan to undergo major surgery during the study period;\n16. Previous malignancies other than the disease under study within 3 years, except for those that can be cured through local treatment, such as skin basal cell carcinoma, cervical or breast cancer in situ;\n17. Pregnant or lactating women;\n18. Participate in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or during the follow-up period of an intervention study;\n19. Has a clear history of neurological or mental disorders, including epilepsy or dementia;\n20. Other circumstances that researchers believe not suitable to participate in clinical trials, including but not limited to: subjects with severe or uncontrollable medical conditions, safety risks, interference with the interpretation of research results, and impact on trial compliance.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study aims to evaluate the safety and tolerability of NBL-020 injection in subjects with advanced malignant tumors, and determine the dose limiting toxicity (DLT), maximum tolerable dose (MTD) (if any), recommended phase II dose (RP2D), and dosing regimen of NBL-020.",[26],"Advanced Malignant Tumors","RECRUITING","2024-03-25",{"date":30,"type":31},"2024-03-26","ACTUAL",{"date":33,"type":31},"2023-08-15",{"date":35,"type":20},"2026-12",{"name":37,"class":38},"NovaRock Biotherapeutics, Ltd","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":39},"100533241","phase-1-a-study-of-nbl-028-in-patients-with-advanced-solid-tumors-100533241","NCT06223256","A Study of NBL-028 in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NBL-028 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients ≥18 years old, should have fully understood the study and voluntarily signed an informed consent form.\n2. Patients with pathologically diagnosed advanced solid tumors with positive expression of CLDN6. Stage I: Patients have failed or cannot tolerate standard of care, or without standard treatment; Stage Ⅱ: Previously treated advanced solid tumors.\n3. Be able to provide previously well-preserved tumor tissue sections, or agree to undergo tumor tissue biopsy for central laboratory biomarker testing.\n4. At least one measurable target lesion according to RECIST 1.1.\n5. ECOG performance status of 0 or 1 at screening.\n6. Life expectancy ≥3 months.\n7. Adequate organ function within 7 days prior to the first dose defined as: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥100×10\\^9\u002FL;. Hemoglobin (HGB) ≥90 g\u002FL; Serum creatinine ≤ 1.5 × ULN or Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥50 mL\u002Fmin; Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN when patients with Gilbert's disease); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN if liver involvement is known).\n8. Serum pregnancy test for women of childbearing potential (WOCBP) is negative within 7 days prior to the first dose of the investigational drug. The patient and his\u002Fher spouse must agree to use adequate contraception from signing of informed consent form (ICF) to 3 months after the last dose, during which women should be non-lactating and men should refrain from donating sperm.\n\nExclusion Criteria:\n\n1. Previously received CLDN6-targeted or CD137-targeted treatment.\n2. Known uncontrolled central nervous system (CNS) cancer including CNS metastasis, meningeal metastasis, or spinal cord compression.\n3. Patients with high risk of bleeding due to tumor invasion of important arteries.\n4. Has uncontrolled serous cavity effusion (such as pleural effusion, abdominal effusion, or pericardial effusion, etc) requiring repeated drainage.\n5. Has adverse events due to previous anti-tumor treatments that have not yet recovered to ≤Grade 1 according to NCI-CTCAE v5.0;\n6. Developed immune-related adverse events (irAE) of grade ≥3 (CTCAE 5.0) with prior immunotherapy\n7. Known to exist any other malignant tumor requiring intervention.\n8. Have received anti-tumor treatments (such as chemotherapy, targeted therapy, biological therapy, etc.) or any other investigational drugs or treatments within 4 weeks or 5 half-lives, whichever is shorter.\n9. Have received a live viral vaccine within 4 weeks before the first dose of study drug.\n10. Have received immunosuppressive medications within 2 weeks prior to the first dose of study drug.\n11. Have active or serious bacterial, fungal, or viral infection requiring systemic anti-infective treatment within 2 weeks prior to the first dose of study drug.\n12. Have received radiation therapy or other localized palliative treatment within 2 weeks before the first dose of study drug.\n13. Have undergone major surgery within 4 weeks before the first dose of study drug, or scheduled to have major surgery during the study.\n14. Have a history of serious cardiovascular disease.\n15. Have active or history of autoimmune diseases.\n16. A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.\n17. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis.\n18. Hypersensitive to humanized monoclonal antibody products.\n19. Women during lactation or pregnancy.\n20. Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration.\n21. Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.",{"count":48,"type":20},270,[23],"This is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion.\n\nDose escalation will be guided by the Bayesian optimal interval (BOIN) design including accelerated titration to determine the maximum tolerated dose (MTD) of NBL-028. Dose expansion - Additional patients (no more than 200) will be enrolled at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Sponsor may elect to enroll specific tumor types into four cohorts.",[52],"Advanced Solid Tumor","2024-03-15",{"date":55,"type":31},"2024-03-18",{"date":57,"type":31},"2024-03-08",{"date":59,"type":20},"2027-01",{"name":37,"class":38},""]