[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653817":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":39,"armGroups":47,"interventions":70,"overallOfficials":99,"centralContacts":104,"locations":109,"responsibleParty":231,"collaborators":233,"id":236,"slug":237,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":39,"eligibilityCriteria":242,"healthyVolunteers":238,"sex":243,"minAge":244,"maxAge":245,"enrollmentInfo":246,"targetDuration":39,"studyType":249,"phases":250,"briefSummary":253,"conditions":254,"keywords":39,"overallStatus":256,"whyStopped":39,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},{"fullName":5,"class":6},"Nanjing Leads Biolabs Co.,Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":39},[9,13],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR)","According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).","From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)",{"measure":14,"description":15,"timeFrame":16},"Occurrence of adverse event (AE) and serious adverse event (SAE)","Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 Combination Therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.","From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)",[18,21,24,27,30,33,36],{"measure":19,"description":20,"timeFrame":12},"Disease Control Rate(DCR）","Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment.",{"measure":22,"description":23,"timeFrame":12},"Duration of Response(DOR）","DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.",{"measure":25,"description":26,"timeFrame":12},"Progression-free Survival(PFS)","According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause.",{"measure":28,"description":29,"timeFrame":12},"Overall survival (OS)","Time from randomization to death for any reason in a clinical trial.",{"measure":31,"description":32,"timeFrame":12},"Cmax","Maximum drug concentration in plasma after administration.",{"measure":34,"description":35,"timeFrame":12},"Tmax","After administration,Time to reach maximum drug concentration in plasma.",{"measure":37,"description":38,"timeFrame":12},"Immunogenicity","The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE","This study included phase Ib (safety introduction period) and phase II (randomized controlled extension period).\n\nPhase Ib and Phase II each contain two independent cohorts, Cohort 1 and Cohort 2.\n\nAfter comprehensive evaluation by the sponsor and investigator, the safety and tolerability of combination therapy in Phase Ib Cohort 1 and Cohort 2 were good, and preliminary efficacy was observed,Participants will be enrolled to conduct the two cohorts of phase II study.The Phase II study design will be adjusted based on results from the Phase Ib study.The population enrolled in Cohort 1 of Phase II will be determined by the results of Cohort 1A and Cohort 1B of Phase Ib.In Cohort 2 of Phase II, eligible participants were randomly assigned to the B1 group and B2 group in a 2: 1 ratio.",[48,55,61,66],{"label":49,"type":50,"description":51,"interventionNames":52},"LBL-024 + bevacizumab","EXPERIMENTAL","LBL-024 + bevacizumab.\n\nIntravenous infusion.",[53,54],"Drug: LBL-024 for Injection","Drug: Bevacizumab injection",{"label":56,"type":50,"description":57,"interventionNames":58},"LBL-024 + bevacizumab + oxaliplatin + capecitabine","LBL-024 + bevacizumab + oxaliplatin + capecitabine.\n\nIntravenous infusion and Oral .",[53,54,59,60],"Drug: Oxaliplatin injection","Drug: Capecitabine tablets",{"label":62,"type":50,"description":63,"interventionNames":64},"LBL-024 + bevacizumab\u002FLBL-024 monotherapy\u002Ffruquintinib monotherapy","LBL-024 + bevacizumab\u002FLBL-024 monotherapy\u002Ffruquintinib monotherapy.\n\nIntravenous infusion or Oral .",[53,54,65],"Drug: Fruquintinib Capsules",{"label":67,"type":50,"description":68,"interventionNames":69},"LBL-024 + bevacizumab + oxaliplatin + capecitabine\u002F bevacizumab + oxaliplatin + capecitabine","LBL-024 + bevacizumab + oxaliplatin + capecitabine\u002F bevacizumab + oxaliplatin + capecitabine.\n\nIntravenous infusion and Oral .",[53,54,59,60],[71,78,83,88,94],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"DRUG","LBL-024 for Injection","intravenous infusion.",[49,56,67,62],[77],"LBL-024",{"type":72,"name":79,"description":74,"armGroupLabels":80,"otherNames":81},"Bevacizumab injection",[49,56,67,62],[82],"Bevacizumab",{"type":72,"name":84,"description":74,"armGroupLabels":85,"otherNames":86},"Oxaliplatin injection",[56,67],[87],"Oxaliplatin",{"type":72,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"Capecitabine tablets","Oral.",[56,67],[93],"Capecitabine",{"type":72,"name":95,"description":90,"armGroupLabels":96,"otherNames":97},"Fruquintinib Capsules",[62],[98],"fruquintinib",[100],{"name":101,"affiliation":102,"role":103},"Ruihua Xu","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[105],{"name":101,"role":106,"phone":107,"phoneExt":39,"email":108},"CONTACT","025-83378099","liulei@leadsbiolabs.com",[110,126,136,148,159,171,183,195,207,219],{"facility":111,"status":39,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China","CN",{"type":118,"coordinates":119},"Point",[120,121],113.25,23.11667,{"lat":121,"lon":120},[124],{"name":125,"role":106,"phone":107,"phoneExt":39,"email":108},"Lei Lui",{"facility":127,"status":39,"city":112,"state":113,"zip":128,"country":115,"countryCode":116,"cosmosGeoPoint":129,"geoPoint":131,"contacts":132},"The Sixth Affiliated Hospital Sun Yat-sen University","510655",{"type":118,"coordinates":130},[120,121],{"lat":121,"lon":120},[133],{"name":134,"role":106,"phone":135,"phoneExt":39,"email":108},"Lei Liu","02583378099",{"facility":137,"status":39,"city":138,"state":139,"zip":140,"country":115,"countryCode":116,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"The First Affiliated Hospital of Guilin Medical University","Guilin","Guangxi","541199",{"type":118,"coordinates":142},[143,144],110.29639,25.28022,{"lat":144,"lon":143},[147],{"name":134,"role":106,"phone":107,"phoneExt":39,"email":108},{"facility":149,"status":39,"city":150,"state":139,"zip":151,"country":115,"countryCode":116,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Guangxi Medical University Cancer Hospital","Nanning","530200",{"type":118,"coordinates":153},[154,155],108.31667,22.81667,{"lat":155,"lon":154},[158],{"name":134,"role":106,"phone":107,"phoneExt":39,"email":108},{"facility":160,"status":39,"city":161,"state":162,"zip":163,"country":115,"countryCode":116,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"The First Affiliated Hospital of Henan University of Science & Technology","Luoyang","Henan","471023",{"type":118,"coordinates":165},[166,167],112.43684,34.67345,{"lat":167,"lon":166},[170],{"name":134,"role":106,"phone":107,"phoneExt":39,"email":108},{"facility":172,"status":39,"city":173,"state":174,"zip":175,"country":115,"countryCode":116,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330006",{"type":118,"coordinates":177},[178,179],115.85306,28.68396,{"lat":179,"lon":178},[182],{"name":134,"role":106,"phone":107,"phoneExt":39,"email":108},{"facility":184,"status":39,"city":185,"state":186,"zip":187,"country":115,"countryCode":116,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Shandong Cancer Hospital","Jinan","Shandong","250117",{"type":118,"coordinates":189},[190,191],116.99722,36.66833,{"lat":191,"lon":190},[194],{"name":134,"role":106,"phone":107,"phoneExt":39,"email":108},{"facility":196,"status":39,"city":197,"state":198,"zip":199,"country":115,"countryCode":116,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Shanghai GoBroad Cancer Hospital","Shanghai","Shanghai Municipality","201300",{"type":118,"coordinates":201},[202,203],121.45806,31.22222,{"lat":203,"lon":202},[206],{"name":134,"role":106,"phone":135,"phoneExt":39,"email":108},{"facility":208,"status":39,"city":209,"state":210,"zip":211,"country":115,"countryCode":116,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Sichuan Cancer Hospital","Chengdu","Sichuan","610041",{"type":118,"coordinates":213},[214,215],104.06667,30.66667,{"lat":215,"lon":214},[218],{"name":134,"role":106,"phone":107,"phoneExt":39,"email":108},{"facility":220,"status":39,"city":221,"state":222,"zip":223,"country":115,"countryCode":116,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality","300060",{"type":118,"coordinates":225},[226,227],117.17667,39.14222,{"lat":227,"lon":226},[230],{"name":134,"role":106,"phone":135,"phoneExt":39,"email":108},{"type":232,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[234],{"name":102,"class":235},"OTHER","100653817","phase-1-a-phase-ibii-clinical-study-of-lbl-024-combination-therapy-in-patients-with-metastatic-colorectal-carcinoma-100653817",false,"NCT07791758","A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma","An Open-label, Multicenter Phase Ib\u002FII Study to Evaluate the Safety and Efficacy of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma","Inclusion Criteria:\n\n1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.\n2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.\n3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\\~1.\n4. The expected survival time is at least 12 weeks.\n5. According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the Participants enrolled have at least one measurable lesion.\n6. There is adequate organ and bone marrow function,Conforms to laboratory test results.\n7. Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.\n\nExclusion Criteria:\n\n1. Participants with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.\n2. Women during pregnancy or lactation.\n3. Participants with mental illness (impairing understanding or ability to give informed consent),history of Drug abuse, alcoholism or drug addiction.\n4. participant had a history of severe cardiovascular and cerebrovascular disorder.\n5. Subjects who received a live vaccine within 4 weeks prior to the first dose or are scheduled to receive a live vaccine during the study treatment period and within 4 weeks after the last dose.\n6. patients with active,Or patients who have had and may recur autoimmune diseases.\n7. patients with active hepatitis B or active hepatitis C.\n8. History of immunodeficiency including HIV antibody test positive.\n9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.","ALL","18 Years","75 Years",{"count":247,"type":248},369,"ESTIMATED","INTERVENTIONAL",[251,252],"PHASE1","PHASE2","This study is an open-label, multi-center Phase Ib\u002FII clinical trial evaluating the safety and efficacy of LBL-024 in combination with other drugs for the treatment of metastatic colorectal carcinoma (mCRC), aiming to evaluate the safety and efficacy of LBL-024 in combination with other drugs in the treatment of mCRC patients.",[255],"Metastatic Colorectal Carcinoma","NOT_YET_RECRUITING","2026-08-31",{"date":259,"type":260},"2026-09-02","ACTUAL",{"date":262,"type":248},"2026-09-04",{"date":264,"type":248},"2030-09-04",{"name":5,"class":6},10]