[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509116":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":11,"studyPopulation":11,"armGroups":43,"interventions":50,"overallOfficials":11,"centralContacts":11,"locations":55,"responsibleParty":74,"collaborators":11,"id":76,"slug":11,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Shandong Boan Biotechnology Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of adverse events (AEs)",null,"From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.",[14,17,19,21,23,26,28,30,32,34],{"measure":15,"description":11,"timeFrame":16},"Maximum Concentration (Cmax) of BA1202","Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)",{"measure":18,"description":11,"timeFrame":16},"Area under the curve (AUC) of BA1202",{"measure":20,"description":11,"timeFrame":16},"Minimum Concentration (Cmin) of BA1202",{"measure":22,"description":11,"timeFrame":16},"Time of maximum concentration (Tmax) of BA1202",{"measure":24,"description":11,"timeFrame":25},"Objective Response Rate (ORR)","up to 2 years",{"measure":27,"description":11,"timeFrame":25},"Disease Control Rate (DCR)",{"measure":29,"description":11,"timeFrame":25},"Duration of Response (DOR)",{"measure":31,"description":11,"timeFrame":25},"Overall Survival (OS)",{"measure":33,"description":11,"timeFrame":25},"Progression-Free Survival (PFS)",{"measure":35,"description":11,"timeFrame":36},"Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab)","Cycle 1: Day 1, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 5 Day 1; Cycle 6 Day 1; EOT (end of treatment) visit. (Each cycle is 21 days.)",{"allocation":38,"interventionModel":39,"interventionModelDescription":11,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"NA","SEQUENTIAL","TREATMENT",{"masking":42,"maskingDescription":11,"whoMasked":11},"NONE",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"BA1202","EXPERIMENTAL","BA1202 is a bispecific antibody targeting CEA and CD3.",[49],"Drug: BA1202",[51],{"type":52,"name":45,"description":53,"armGroupLabels":54,"otherNames":11},"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.",[45],[56],{"facility":57,"status":58,"city":59,"state":11,"zip":11,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":63,"coordinates":64},"Point",[65,66],116.39723,39.9075,{"lat":66,"lon":65},[69],{"name":70,"role":71,"phone":72,"phoneExt":11,"email":73},"Huang Jing","CONTACT","13301056087","huangjingwg@163.com",{"type":75,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":86,"type":87},78,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93],"Advanced Solid Tumor","2024-04-24",{"date":96,"type":97},"2024-04-25","ACTUAL",{"date":99,"type":97},"2023-08-16",{"date":101,"type":87},"2026-12",{"name":5,"class":6},1]