[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Innolake Biopharm\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100548875","phase-1-a-study-of-the-ilb-3101-in-patients-with-advanced-solid-tumors-100548875",false,"NCT06426680","A Study of the ILB-3101 in Patients with Advanced Solid Tumors","Phase I\u002FII Study of the ILB-3101 in Patients with Advanced Solid Tumors","Inclusion Criteria:\n\n1. Have signed informed consent forms voluntarily.\n2. 18-80 years old.\n3. Having an ECOG performance status score of 0 or 1.\n4. With an expected survival of more than 12 weeks.\n5. Diagnosed histologically or cytologically with local advanced or metastatic solid cancer, and under one of following situations: standard treatment-refractory (disease progression or no response), treatment-resistant, unable to receive treatment, or the standard treatment is unavailable.\n6. Need to provide archived tumor tissue samples (Formalin fixed or paraffin embedded tissue blocks or at least 5 unstained sections); During the dose escalation stage, for subjects who are unable to provide tumor samples or have insufficient samples, the decision to enroll may be made based on specific circumstances after discussion with the sponsor.\n7. At least one assessable tumor lesion is present during the dose escalation phase, and according to RECIST version 1.1, at least one measurable tumor lesion is present during the dose escalation phase (CRPC can be determined based on PCWG3).\n8. Having sufficient bone marrow, liver, and kidney functions (based on the normal value of the clinical trial site):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL.\n   2. Platelets ≥ 75×109\u002FL.\n   3. Hemoglobin ≥ 90g\u002FL.\n   4. Total serum bilirubin ≤ 1.5×upper limit of normal (ULN).\n   5. Without liver metastases, ALT, AST ≤ 2.5×ULN; with liver metastases, ALT, AST ≤ 5×ULN.\n   6. Serum creatinine ≤1.5 × ULN.\n   7. Creatinine clearance rate (CrCl) (creatinine only ˃ Calculation required for 1.5 × ULN ≥50 mL\u002Fmin (Calculate according to Cockcroft Fault formula),\n   8. International Normalized Ratio (INR) ≤ 1.5×ULN, APTT ≤ 1.5×ULN.\n   9. Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.\n   10. QT interval corrected by Fridericia method (QTcF) Male\\\u003C450ms; Female\\\u003C470ms.\n9. The serum pregnancy test results of female subjects of childbearing age are negative.\n10. Male or female patients of childbearing potential must agree to use effective methods of contraception (such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives and intrauterine devices) during the study period and within 90 days after the last dosing.\n\nExclusion Criteria:\n\n1. Within 3 weeks prior to the first administration, systemic anti-tumor therapy has been received, including chemotherapy, curative radiotherapy (palliative radiotherapy for a single lesion within 3 weeks prior to enrollment is allowed, and radiotherapy is not allowed for measurable lesions before enrollment unless it is confirmed that the lesion has progressed after radiotherapy), biological therapy, immunotherapy, etc., except for the following:\n\n   1. Received urea nitrite or mitomycin C within 6 weeks prior to the first use of the study drug.\n   2. Oral administration of fluorouracil or small molecule targeted drugs within 2 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is longer).\n   3. Individuals who have received endocrine therapy within 2 weeks prior to the first use of the investigational drug.\n   4. Traditional Chinese patent medicines and simple preparations or traditional Chinese medicine with anti-tumor indication within 1 week before the first use of the study drug.\n2. Patients who received other clinical trial drug within 4 weeks before the first dosing.\n3. Within 3 years prior to the first trial drug treatment, the patient had other active malignant tumors, except for the tumors participating in this study and other locally cured tumors (such as basal skin cancer, papillary thyroid cancer, or any type of in situ cancer that has been completely removed, such as cervical in situ cancer, ductal carcinoma in situ, etc.).\n4. The presence of clinically uncontrollable pleural\u002Fabdominal effusion, pericardial effusion, determined by the investigators as unsuitable for inclusion.\n5. Suffering from central nervous system metastasis and\u002For cancerous meningitis. Except for asymptomatic or asymptomatic central nervous system metastases that have been clinically controlled but are judged stable by investigators, the following conditions must also be met:\n\n   1. Stable clinical symptoms for at least 4 weeks before receiving trial drug treatment.\n   2. No evidence of central nervous system disease progression was found in imaging examinations within 4 weeks prior to the first trial drug treatment.\n   3. Antiepileptic drugs have been discontinued at least 2 weeks prior to the first trial drug treatment, and the dosage of prednisone is ≤ 10mg\u002Fday or equivalent dose of steroids.\n   4. For patients with intracranial lesions, if they have received treatment (such as radiotherapy) before the first trial drug treatment, elution should be ≥ 2 weeks. Cancer induced encephalitis should be excluded regardless of its stable clinical condition.\n6. Receiving drug therapy known to prolong the QT interval or potentially lead to torsade de pointe ventricular tachycardia; Or continue to receive these medications during the research period.\n7. Acute coronary syndrome occurring within the past 6 months, including myocardial infarction, unstable angina, symptomatic congestive heart failure (New York Heart Association classification II-IV), aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events; Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III-degree atrioventricular block, etc.\n8. Suffering from clinically uncontrollable diseases, including but not limited to severe diabetes (diabetes ketoacidosis or hyperglycemia hyperosmolality occurred within 6 months before the first administration, and the detection value of glycosylated hemoglobin in the screening period was ≥ 7.5%); Refractory hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg after optimal medical treatment within the first month of screening) or a history of hypertensive crisis or hypertensive encephalopathy.\n9. Individuals with previous or current interstitial lung disease (excluding radiation pneumonia that does not require hormone therapy).\n10. Evidence of persistent uncontrolled systemic bacterial, fungal, or viral infections (including HIV infection, HIV antibody positive; syphilis infected individuals) and current need for intravenous anti infection treatment.\n11. Provisions on hepatitis B and hepatitis C: if hepatitis B surface antigen (HBsAg) is positive, and HBV-DNA\\>2000 IU\u002Fml or 104 copies\u002Fml, hepatitis B virus infected persons should receive antiviral treatment according to local guidelines and standards and are willing to receive antiviral treatment throughout the study period; Hepatitis C antibody positive, and HCV RNA higher than the upper limit of normal values in the study site;\n12. Within 14 days prior to the first administration, systemic corticosteroids (prednisone\\>10mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressive treatments have been received, except for the following:\n\n    1. Use local, ocular, intra-articular, intranasal, and inhaled corticosteroids for treatment.\n    2. short term use of glucocorticoids for preventive treatment (such as preventing contrast agent allergies).\n13. Within 4 weeks before the first administration or planned to receive attenuated live vaccines during the study period.\n14. Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first administration or requiring elective surgery during the trial period.\n15. Individuals who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past.\n16. Known to have alcohol or drug dependence.\n17. Individuals with mental disorders or poor compliance.\n18. The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE5.0 ≤ Grade 1 (excluding toxicity judged by the investigators to have no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.);\n19. Known to cause clinically significant allergic reactions to the active ingredients and excipients, antibodies, and other monoclonal antibodies.\n20. Pregnant (positive pregnancy test prior to dosing) or breast-feeding women.\n21. The investigators believe that the subjects are not suitable to participate in this clinical study due to other reasons.","ALL","18 Years","80 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients.",[27],"Advanced Solid Tumor","RECRUITING","2024-12-04",{"date":31,"type":32},"2024-12-09","ACTUAL",{"date":34,"type":32},"2024-10-30",{"date":36,"type":21},"2026-03",{"name":38,"class":39},"Innolake Biopharm","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":40},"100512642","phase-1-a-study-of-ilb2109-and-toripalimab-in-patients-with-advanced-solid-malignancies-100512642","NCT05955105","A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies","A Phase Ib\u002FIIa, Multicenter, Open-label Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Adult patients between the ages of 18 and 80 years.\n2. Patients with histologically or cytologically confirmed solid tumours that are advanced, metastatic and or progressive, for whom there is no effective standard therapy available.\n3. Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2.\n4. Expected life expectancy ≥3 months.\n5. Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Eisenhauer, et al. 2009).\n6. Laboratory values at Screening:\n\n   Absolute neutrophil count ≥1.5 x 109\u002FL; Platelets ≥75 x 109\u002FL; Hemoglobin ≥ 90g\u002FL; Total bilirubin \\\u003C1.5 times the upper limit of normal; Aspartate aminotransferase (AST) ≤3 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Estimated glomerular filtration rate (GFR) of \\>50 mL\u002Fmin (based on the Cockcroft-Gault formula; International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT) ≤1.5 times the upper limit of normal; Left Ventricular Ejection Fraction (LVEF) ≥ 50%; Corrected QT Interval by Fridericia Method: male\\\u003C450ms, female\\\u003C470ms; and\n7. Negative human chorionic gonadotropin (hCG) test in women of childbearing potential.\n8. Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and\u002For intrauterine devices) during the entire duration of the study and for 90 days after final administration of ILB-2109, or the patient must be surgically sterile .\n9. Ability to give written, informed consent prior to any study-specific Screening procedures.\n\nExclusion Criteria:\n\n1. In the past 3 weeks: received systemic anti-tumor therapy, including chemotherapy, radiation, biologics, androgen, targeted therapy and immunotherapy with the following exceptions: i. received treatment containing nitrosoureas or mitomycin C in the past 6 weeks; ii. received oral fluorouracil or small molecule targeted therapy or Chinese Traditional Medicine (CTM) with anti-neoplasm indication in the past 2 weeks ;\n2. In the past 4 weeks: received any other investigational treatment;\n3. Gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption;\n4. Uncontrollable third-spacing of fluids;\n5. Known CNS metastasis with clinical symptoms or the need of steroid treatment or CNS lesion ≥ 1.5cm or with the evidence of lesion enlargement in the past 4 weeks;\n6. Severe cardiovascular diseases including symptomatic heart failure (NYHA Class II and above), unstable angina, arrythmia, myocardial infarction within the past 6 months, embolism or pulmonary embolism within the past 3 months;\n7. Having any risk factors of QT prolongation, including present or family history of long QT syndrome or using any medication with known QT prolongation effect;\n8. Poor controlled chronic diseases, including poorly controlled diabetes mellitus (defined as HbA1c ≥ 8.5%), poorly controlled hypertension, has a history of hypertensive emergency or hypertensive encephalopathy, endocrine diseases that require systemic therapy;\n9. Current diagnosis of interstitial pneumonia or a history of chronic emphysema, COPD, or TB infection;\n10. Autoimmune diseases that required systemic therapy within the past 2 years, with the exception of vitiligo, asthma, atopic diseases and autoimmune thyroid diseases that are stable on thyroid replacement therapy;\n11. Active infection with the need if IV antibiotic treatment;\n12. Known HIV infection;\n13. Active HBV infection (defined as positive HBsAg and HBV-DNA\\>500 IU\u002Fml), active HCV infection (positive HCV antibody but HCV-RNA \\\u003C lower limit of detection is allowed to participate);\n14. Known syphilis infection;\n15. Received systemic steroid at a dose greater or equivalent to 10mg of prednisone per day or other immune modulating treatments in the past 14 days;\n16. Plan to receive live vaccine during the study period (4 weeks prior to the 1st dose till 6 months after the last dose);\n17. Major surgery within the past 4 weeks;\n18. Previous allogeneic bone marrow transplant or solid organ transplant;\n19. Known history of psychiatric disease\u002Falcohol or drug abuse that would affect subject's compliance to trial protocol;\n20. Any unresolved toxicities from prior therapies higher than CTCAE grade 1 with the following exceptions: i. alopecia; ii. peripheral neuropathy; iii. thyroid function abnormalities that can be treated with replacement therapy;\n21. Known history of CTCAE grade 3 and above irAE in previous immunotherapies;\n22. Known allergy to ILB-2109 or Toripalimab;\n23. Subjects who are currently pregnant or breastfeeding;\n24. Other conditions that in the opinion of the investigator will make the subject unfit to participate in this trial;",{"count":49,"type":21},200,[24,51],"PHASE2","This is a multicenter, open-label, phase Ib\u002FIIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.",[54,55,56,57,58,59,60,61,62,63],"Head and Neck Cancer","Cervical Cancer","Endometrial Cancer","Triple Negative Breast Cancer","Ovarian Cancer","Soft Tissue Sarcoma","Melanoma","Nasopharyngeal Carcinoma","Non Small Cell Lung Cancer","Classic Hodgkin Lymphoma","2024-05-19",{"date":66,"type":32},"2024-05-21",{"date":68,"type":32},"2023-07-25",{"date":70,"type":21},"2026-07-24",{"name":38,"class":39},""]