[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shandong Boan Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,65,86],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100561957","phase-1-safety-and-efficacy-of-ba1302-in-patients-with-advanced-solid-tumors-100561957",false,"NCT06596915","Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n* 1\\. Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. Patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available.\n\n  1. Part A: Advanced malignant solid tumors;\n  2. Part B: Metastatic melanoma, Advanced breast cancer, Advanced Non-small cell lung cancer (NSCLC), Advanced pancreatic adenocarcinoma.\n* 2.Participants should be able to provide adequate tumor tissue for biomarker analysis\n* 3.ECOG Performance Status ≤ 1.\n* 4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)\n\nExclusion Criteria:\n\n* 1\\. Malignant disease within 5 years prior to the first dose of investigational drug other than that being treated in this study. Except completely resected basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary thyroid carcinoma and completely resected carcinoma in situ of any type.\n* 2\\. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication or other anti-cancer treatment within 28 days prior to the first dose.\n* 3.History of severe hypersensitivity reactions to any ingredient of study drugs.\n* 4.Pregnant or lactating women.\n* 5.Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.","ALL","18 Years",{"count":19,"type":20},167,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).",[26,27,28,29],"Non-Small Cell Lung Cancer","Pancreatic Adenocarcinoma","Breast Cancer","Melanoma","RECRUITING","2025-06-03",{"date":33,"type":34},"2025-06-06","ACTUAL",{"date":36,"type":34},"2024-09-11",{"date":38,"type":20},"2026-12-30",{"name":40,"class":41},"Shandong Boan Biotechnology Co., Ltd","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":42},"100587358","phase-1-a-trial-to-evaluate-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-ba1301-in-advanced-solid-tumors-100587358","NCT06927349","A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors.","An Non-randomized Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy of BA1301in Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan;\n2. Age ≥ 18 years old and ≤ 75 years old, male or female;\n3. Patients with locally advanced or metastatic malignant solid tumours that cannot be surgically resected as histologically or cytologically confirmed by standard therapy failure or refusal or inability to tolerate standard treatment regimens.\n4. Agree to provide archival or fresh tumour tissue for immunohistochemical evaluation for immunohistochemical detection of CLDN18.2 expression.\n5. Eastern Cooperative Oncology Group (ECOG) Strength Status Score of 0 or 1.\n6. At least one evaluable lesion according to the efficacy evaluation criteria for solid tumours (RECIST1.1).\n7. Adequate organ function.\n8. Estimated survival ≥ 3 months;\n9. Negative blood pregnancy test result for females of childbearing potential at screening.\n\nExclusion Criteria:\n\n1. Poorly controlled hypertension as judged by the investigator\n2. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC drug therapy, major surgery, or other anti-cancer therapy within 28 days prior to the first dose of trial drug.\n3. Known hypersensitivity to any ingredient of the therapeutic drug used in the study protocol;\n4. Positive hepatitis B virus surface antigen (HBsAg) test; Positive hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody;\n5. Pregnant or lactating females, those who have recently planned to become pregnant;\n6. Those who have participated in and received any clinical trial drugs (excluding vitamins and minerals) or clinical trial device intervention within 28 days before signing informed consent;\n7. Other serious physical or psychiatric illness or laboratory test abnormalities at screening that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable to participate in this study.","75 Years",{"count":52,"type":20},70,[23],"This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1301 in participants with advanced solid tumors.",[56],"Advanced Solid Tumours","2025-04-07",{"date":59,"type":34},"2025-04-15",{"date":61,"type":34},"2023-01-11",{"date":63,"type":20},"2026-12-31",{"name":40,"class":41},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":42},"100517847","phase-3-a-study-to-compare-the-efficacy-and-safety-of-ly01015-and-opdivo-combined-respectively-with-chemotherapy-in-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-100517847","NCT06022861","A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma","A Randomized, Double-blind, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of LY01015 and Opdivo®（Nivolumab Injection）Combined Respectively With Fluorouracil Plus Cisplatin in Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma.","Inclusion Criteria:\n\n1. Willing to sign the informed consent form.\n2. Male or female aged 18 to 75 years patients.\n3. Histopathologically confirmed esophagus squamous cell carcinoma.\n4. Diagnosed with advanced or metastatic ESCC per AJCC 8th edition, not be amenable to curative approaches( such as definitive chemoradiation\u002Fsurgery), not received prior systemic anti-cancer therapy for progressive or metastatic disease. Prior neoadjuvant, adjuvant or definitive radiotherapy\u002Fchemoradiotherapy\u002Fchemotherapy for locally advanced diseases is permitted if time from the last dose to recurrence\\> 24 weeks.\n5. Must have at least one measurable lesion assessed by investigator per RECIST 1.1 criteria .\n6. ECOG performance status of 0 to 1.\n7. Prior to the first dose, the tumor tissue samples must be provided for PD-L1 expression analysis, and PD-L1 TPS≥1%.\n8. Expected survival ≥6 months.\n9. Adequate organ function at screening.\n\nExclusion Criteria:\n\n1. Presence of symptomatic brain metastasis or spinal compression, or history of meningeal metastasis. Patients with asymptomatic brain metastases who have received prior treatment are permitted to enroll if the disease is stable, and corticosteroids have not been required for at least 4 weeks prior to screening. Patients with carcinomatous meningitis are ineligible, regardless of whether the disease is clinically stable or not.\n2. With high risks of bleeding or fistula due to apparent tumor invasion to esophagus or adjacent organs.\n3. Known endoscopy-confirmed near-complete obstruction requiring interventional therapy or with risk of perforation post stent implantation in the esophagus or trachea.\n4. Unstable disease within 6 months prior to signing informed consent form, including but not limited to unstable angina, myocardial infarction, NYHA Class II or higher cardiac failure, severe arrhythmia or cerebrovascular accident (including transient ischemic attacks) requiring treatment, or any other poorly-controlled systemic disease, for example, uncontrolled hypertension (systolic pressure ≥160 mmHg or diastolic pressure≥100 mmHg) despite standard treatment.\n5. Received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 agent or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n6. Prior cumulative exposure dose of cisplatin\\>300 mg\u002Fm2 and time from the last dose of cisplatin to randomization ≤12 month.\n7. Received a live vaccine within 4 weeks prior to the first dose, or be scheduled to receive a live vaccine during the entire course of the study.\n8. Received systemic chemotherapy, targeted therapy, immunosuppressants, immunostimulants, biological agents, Chinese herbal medicines for anti-tumor indications (prescription or medical record required), Chinese patent drug or any other investigational agents or participated in interventional clinical study within 4 weeks (or five half-lives, whichever is longer) prior to the first dose.\n9. Other conditions, as determined by the investigator, for example, severe deep vein thrombosis, arterial embolism, hepatic encephalopathy, Child-Pugh grade B or more severe cirrhosis, or other acute or chronic disease, mental illnesses or laboratory abnormalities, which may lead to the following consequences: increase the risks associated with study participation or study drug administration, or interfere with the interpretation of study results.",{"count":73,"type":20},510,[75],"PHASE3","This is a randomized, double-blind, multicenter, Phase 3 study to compare the efficacy and safety of LY01015 and Opdivo®（Nivolumab Injection）combined respectively with fluorouracil plus cisplatin in participants with unresectable advanced, recurrent or metastatic previously untreated esophageal squamous cell carcinoma.",[78],"Esophageal Squamous Cell Carcinoma",{"date":80,"type":34},"2024-09-19",{"date":82,"type":34},"2023-10-12",{"date":84,"type":20},"2026-12",{"name":40,"class":41},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":106,"locationsCount":42},"100509116","phase-1-a-study-of-ba1202-in-patients-with-advanced-solid-tumors-100509116","NCT05909241","A Study of BA1202 in Patients With Advanced Solid Tumors","A Multicenter, Open-label, Single-arm, Dose Escalation and Expansion Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1202 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients who voluntarily sign an IRB-approved informed consent form, and are willing to abide by the restrictions of the study.\n* Part A: Patients with histologically and\u002For cytologically confirmed advanced and\u002For metastatic solid tumors who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.\n* Part B: Patients with histologically and\u002For cytologically confirmed colorectal cancer, non-small cell lung cancer, pancreatic cancer, gastric cancer, who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.（Specific cohort will be determined after data of dose escalation phase is obtained）\n* Part B: High expression of CEACAM5 (defined as ≥ 20% of tumor cells with IHC 2+ and\u002For 3+).\n* Life expectancy of at least 3 months.\n* At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1.\n* ECOG score of \\\u003C 2.\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL, platelet count ≥ 100 x 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL.\n* Total bilirubin ≤ 1.5×ULN, ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases).\n* Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥50 mL\u002Fmin.\n* International normalized ratio (INR) prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.\n* Blood pregnancy test results were negative for female patients with fertility potential. Patients with fertility potential must agree to use a reliable method of contraception with their sexual partners during the study period and at least 6 months after the last administration.\n\nExclusion Criteria:\n\n* Other malignancies within 5 years prior to screening (other than cured stage Ib or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer).\n* Has a persistent or active infection that requires intravenous treatment.\n* History of severe cardiovascular and cerebrovascular disease.\n* Patients with autoimmune diseases requiring drug control or at risk of recurrence of autoimmune diseases.\n* Received any radiotherapy (other than palliative radiotherapy for bone metastases), chemotherapy, targeted therapy, immunotherapy, cell therapy, or other investigational anticancer agents within 4 weeks prior to first dose of BA1202, unless chemotherapy or targeted therapy is less than 4 weeks after first dose but has eluted ≥5 half-lives.\n* Have received any previous CEA targeting therapy, including but not limited to monoclonal antibodies, bisspecific antibodies, antibody-coupled drugs (ADCs), chimeric antigen receptor T cells (CAR-T), etc.\n* A history of allergy to BA1202 or any component of Obinutuzumab, or to other monoclonal antibodies.\n* Women are planning to become pregnant or are pregnant or breastfeeding.\n* Other conditions considered unsuitable for enrollment by the investigator.","70 Years",{"count":95,"type":20},78,[23],"This is a multicenter, open-label, single-arm phase I study in patients with advanced solid tumors which consists of a dose escalation part (Part A) and a dose extension part (Part B).\n\nPart A aims to evaluate the safety and tolerability of BA1202, and determine the MTD. Part B will also evaluate the preliminary efficacy of BA1202.",[99],"Advanced Solid Tumor","2024-04-24",{"date":102,"type":34},"2024-04-25",{"date":104,"type":34},"2023-08-16",{"date":84,"type":20},{"name":40,"class":41},""]