[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629442":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":11},{"fullName":5,"class":6},"Multitude Therapeutics Inc.","INDUSTRY",[8,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"AMT-676(dose level 1)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)","EXPERIMENTAL",null,[13,14,15,16,17],"Drug: AMT-676","Drug: 5-FU","Drug: Leucovorin","Drug: Bevacizumab","Drug: Cetuximab",{"label":19,"type":10,"description":11,"interventionNames":20},"AMT-676(dose level 2)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)",[13,14,15,16,17],{"label":22,"type":10,"description":11,"interventionNames":23},"oxaliplatin\u002Firinotecan+5-FU+ leucovorin +bevacizumab (or cetuximab)",[14,15,16,17,24,25],"Drug: Irinotecan","Drug: Oxaliplatin",[27,32,36,40,44,48,52],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","AMT-676","Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) or every 4 weeks (Q4W).",[9,19],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"5-FU","5-FU 400 mg\u002Fm\\^2 IV bolus on day 1, followed by 1200 mg\u002Fm\\^2\u002Fday x 2 days (total 2400 mg\u002Fm\\^2 over 46-48 hours) IV continuous infusion, q2w",[9,19,22],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Leucovorin","Leucovorin 400 mg\u002Fm\\^2 IV day 1, q2w",[9,19,22],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Bevacizumab","Bevacizumab 5 mg\u002Fkg IV, day 1",[9,19,22],{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"Cetuximab","Cetuximab 500 mg\u002Fm\\^2 IV over 2 hours, day 1, q2w",[9,19,22],{"type":28,"name":49,"description":50,"armGroupLabels":51,"otherNames":11},"Irinotecan","Irinotecan 180 mg\u002Fm\\^2 IV, day 1",[22],{"type":28,"name":53,"description":54,"armGroupLabels":55,"otherNames":11},"Oxaliplatin","Oxaliplatin 85 mg\u002Fm\\^2 IV, day 1",[22],{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100629442","phase-2-a-phase-ii-study-of-amt-676-combination-therapies-in-advanced-colorectal-cancer-100629442",false,"NCT07474727","A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer","An Phase II Study Evaluating the Safety and Efficacy of AMT-676 in Combination With 5-fluorouracil, Leucovorin, Bevacizumab (or Cetuximab) in Participants of Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements\n* Patients with pathologically confirmed, unresectable advanced colorectal adenocarcinoma\n* Patients must have at least one measurable lesion as per RECIST version 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Life expectancy ≥6 months\n* Patients must have adequate organ function\n* Male and female individuals with child bearing potential must agree to take effective contraceptive measures from the moment they sign the informed consent form until 6 months after the last administration of the study drug\n* WCBP(Women of Child-Bearing Potential) must have a negative serum pregnancy test within 7 days prior to first dose of the IMP\n* Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 3 months and 6 months, respectively, after the last dose of the IMP(Investigational Medicinal Product)\n* Availability of tumor tissue sample\n\nExclusion Criteria:\n\n* Prior treatment with any same target\n* Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP\n* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \\>1\n* Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention, or a surgery is planned to be conducted within the expected participation period of the trial or within 4 weeks after the last administration of the drug\n* History of thromboembolic or cerebrovascular events during last 6 mouths\n* During the three months prior to the first administration of the drug, there were any life-threatening bleeding events, or grade 3 or higher gastrointestinal\u002Fvenous variceal bleeding events that required blood transfusion, endoscopy, or surgical treatment. Or there were other diseases that the researchers believed posed a higher risk of bleeding or thrombosis during the study period\n* Has a history of interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis , or other lung disease significantly impacting lung function at baseline.\n* Any other concurrent diseases or conditions that could affect the research judgment or impede the completion of the research procedures and follow-up checks\n* Central nervous system (CNS) metastasis\n* Have a history of active or acute diverticulitis, abdominal abscess, gastrointestinal obstruction, fistula, or peritoneal cancer\n* Any evidence indicates severe or uncontrolled systemic diseases\n* Acute and\u002For clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).\n* Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP\n* Patients requiring concurrent treatment of strong\u002Fmoderate inhibitors or strong inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment\n* Known or suspected severe allergy\u002Fhypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies\n* Known or suspected intolerance to the components of the IMP\n* Concurrent participation in another investigational therapeutic clinical trial\n* Pregnant or breast-feeding females\n* Investigator determined that the trial participants who were not suitable to participate in this study for other reasons","ALL","18 Years","80 Years",{"count":69,"type":70},180,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This study is an open, multi-center, phase II study, aiming to evaluate the safety, tolerability and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, bevacizumab (or cetuximab) in participants with advanced colorectal cancer, and to assess the PK(Pharmacokinetic) characteristics and immunogenicity of AMT-676.",[76],"Colorectal Cancer","NOT_YET_RECRUITING","2026-03-11",{"date":80,"type":81},"2026-03-16","ACTUAL",{"date":83,"type":70},"2026-04-01",{"date":85,"type":70},"2028-02-28",{"name":5,"class":6}]