[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509116":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":39,"collaborators":19,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":19,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":19,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"Shandong Boan Biotechnology Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BA1202","EXPERIMENTAL","BA1202 is a bispecific antibody targeting CEA and CD3.",[13],"Drug: BA1202",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","BA1202 will be administered intravenously (IV) once every 3 weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the duration of administration was no more than 2 years.\n\nPart A: Patients will receive one of the following dosages of BA1202: 0.016mg, 0.08mg, 0.4mg, 1.6mg, 6.4mg, 19mg, 38mg, 56mg.\n\nPart B: Based on the data of part A, one or two dose levels will be discussed for further evaluation in part B.",[9],null,[21],{"facility":22,"status":23,"city":24,"state":19,"zip":19,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":28,"coordinates":29},"Point",[30,31],116.39723,39.9075,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":19,"email":38},"Huang Jing","CONTACT","13301056087","huangjingwg@163.com",{"type":40,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100509116","phase-1-a-study-of-ba1202-in-patients-with-advanced-solid-tumors-100509116",false,"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.","ALL","18 Years","70 Years",{"count":52,"type":53},78,"ESTIMATED","INTERVENTIONAL",[56],"PHASE1","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.",[59],"Advanced Solid Tumor","2024-04-24",{"date":62,"type":63},"2024-04-25","ACTUAL",{"date":65,"type":63},"2023-08-16",{"date":67,"type":53},"2026-12",{"name":5,"class":6},1]