[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551792":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":32,"locations":37,"responsibleParty":121,"collaborators":32,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":32,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":32,"enrollmentInfo":132,"targetDuration":32,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":145,"whyStopped":32,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Safety Run-In Cohort 1: Telisotuzumab Adizutecan Dose A","EXPERIMENTAL","Participants with unresectable locally advanced\u002Fmetastatic colorectal cancer (CRC) will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration.",[13],"Drug: Telisotuzumab Adizutecan",{"label":15,"type":10,"description":16,"interventionNames":17},"Safety Run-In Cohort 2: Telisotuzumab Adizutecan Dose B","Participants with unresectable locally advanced\u002Fmetastatic CRC will receive telisotuzumab adizutecan dose B during the approximately 2.5 year study duration.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Expansion Part 1: Telisotuzumab Adizutecan Dose A","Participants with unresectable locally advanced\u002Fmetastatic CRC will receive telisotuzumab adizutecan dose A during the approximately 2.5 year study duration.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Dose Expansion Part 2: Telisotuzumab Adizutecan Dose C","If further analysis is warranted, participants with unresectable locally advanced\u002Fmetastatic CRC will receive telisotuzumab adizutecan dose C during the approximately 2.5 year study duration.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Telisotuzumab Adizutecan","Intravenous (IV) Infusion",[19,23,9,15],null,[34],{"name":35,"affiliation":5,"role":36},"ABBVIE INC.","STUDY_DIRECTOR",[38,51,61,71,81,91,101,111],{"facility":39,"status":32,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":32},"Beijing Cancer Hospital \u002FID# 263297","Beijing","Beijing Municipality","100142","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},{"facility":52,"status":32,"city":53,"state":54,"zip":55,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":60,"contacts":32},"The Sixth Affiliated Hospital of Sun Yat-sen University \u002FID# 263309","Guangzhou","Guangdong","510655",{"type":46,"coordinates":57},[58,59],113.25,23.11667,{"lat":59,"lon":58},{"facility":62,"status":32,"city":63,"state":64,"zip":65,"country":43,"countryCode":44,"cosmosGeoPoint":66,"geoPoint":70,"contacts":32},"Harbin Medical University Cancer Hospital \u002FID# 263049","Harbin","Heilongjiang","150081",{"type":46,"coordinates":67},[68,69],126.65,45.75,{"lat":69,"lon":68},{"facility":72,"status":32,"city":73,"state":74,"zip":75,"country":43,"countryCode":44,"cosmosGeoPoint":76,"geoPoint":80,"contacts":32},"Henan Cancer Hospital \u002FID# 263172","Zhengzhou","Henan","450008",{"type":46,"coordinates":77},[78,79],113.64861,34.75778,{"lat":79,"lon":78},{"facility":82,"status":32,"city":83,"state":84,"zip":85,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":32},"Hubei Cancer Hospital \u002FID# 263248","Wuhan","Hubei","430079",{"type":46,"coordinates":87},[88,89],114.26667,30.58333,{"lat":89,"lon":88},{"facility":92,"status":32,"city":93,"state":94,"zip":95,"country":43,"countryCode":44,"cosmosGeoPoint":96,"geoPoint":100,"contacts":32},"The First Affiliated Hospital of Nanchang University \u002FID# 263193","Nanchang","Jiangxi","330006",{"type":46,"coordinates":97},[98,99],115.85306,28.68396,{"lat":99,"lon":98},{"facility":102,"status":32,"city":103,"state":104,"zip":105,"country":43,"countryCode":44,"cosmosGeoPoint":106,"geoPoint":110,"contacts":32},"First Affiliated Hospital of China Medical University \u002FID# 263338","Shenyang","Liaoning","110001",{"type":46,"coordinates":107},[108,109],123.43278,41.79222,{"lat":109,"lon":108},{"facility":112,"status":32,"city":113,"state":114,"zip":115,"country":43,"countryCode":44,"cosmosGeoPoint":116,"geoPoint":120,"contacts":32},"The Second Affiliated Hospital of College of Medicine - Zhejiang University \u002FID# 263094","Hangzhou","Zhejiang","310000",{"type":46,"coordinates":117},[118,119],120.16142,30.29365,{"lat":119,"lon":118},{"type":122,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100551792","phase-1-study-to-assess-adverse-events-and-how-intravenously-iv-infused-telisotuzumab-adizutecan-abbv-400-moves-through-the-body-of-adult-participants-with-unresectable-locally-advancedmetastatic-colorectal-cancer-100551792",false,"NCT06464692","Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Adizutecan (ABBV-400) Moves Through the Body of Adult Participants With Unresectable Locally Advanced\u002FMetastatic Colorectal Cancer","A Phase 1b Study to Evaluate Safety and Pharmacokinetics (PK) of Telisotuzumab Adizutecan (ABBV-400) in Chinese Subjects With Unresectable Locally Advanced\u002FMetastatic Colorectal Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Has histologically or cytologically confirmed unresectable advanced\u002Fmetastatic colorectal cancer (mCRC).\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n* Does not harbor the BRAF V600E mutation and is not deficient mismatch repair (dMMR)+\u002Fmicrosatellite instability (MSI)-High.\n* Stage 2 only:\n\n  * Archival or recently obtained tumor material must be submitted for assessment of c-Met protein levels by an AbbVie designated IHC laboratory during the pre-screening period. Tumor material from the primary tumor site and\u002For metastatic sites are allowed. If archival tissue is negative for c-Met protein expression with 3+ intensity, \\>= 10% tumor cells, recently obtained biopsy material may be submitted for reassessment of c-Met protein expression with 3+ intensity, \\>= 10% tumor cells.\n\nExclusion Criteria:\n\n* History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.\n* Prior systemic regimen containing c-Met protein targeting antibody (e.g., amivantamab-vmjw, ABT-700) or define: antibody-drug conjugate (ADC). Tyrosine kinase inhibitors (TKIs) of Met protein are allowed.\n* History of Interstitial lung disease (ILD)\u002Fpneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* History of clinically significant, intercurrent lung-specific illnesses including, but not limited to:\n\n  * Underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, dependence on supplemental oxygen, etc.)\n  * Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) and prior pneumonectomy.\n* No resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade \\\u003C= 1 prior to study entry, except for neutropenia (Grade \\\u003C= 2), peripheral neuropathy (Grade \\\u003C= 2), and alopecia (any grade).\n* Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year Overall Survival \\[OS\\] rate \\> 90%).","ALL","18 Years",{"count":133,"type":134},31,"ACTUAL","INTERVENTIONAL",[137],"PHASE1","Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and how telisotuzumab adizutecan moves through the body of adult participants with unresectable locally advanced\u002Fmetastatic CRC.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Study doctors put the participants in cohorts called treatment arms. Each treatment arm receives a different dose of telisotuzumab adizutecan. This study will include a dose escalation phase followed by a dose expansion phase. Up to approximately 30 adult participants with unresectable locally advanced\u002Fmetastatic CRC, will be enrolled in the study in approximately 8 sites in China.\n\nIn the dose escalation arms, participants will receive escalating doses of intravenously (IV) infused telisotuzumab adizutecan dose A or B. In dose expansion arm part 1, participants will receive dose A of IV infused telisotuzumab adizutecan. In dose expansion arm part 2, participants will receive the dose C of IV infused telisotuzumab adizutecan. The total study duration will be approximately 2.5 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[140],"Colorectal Cancer",[140,142,143,144],"CRC","Telisotuzumab Adizutecan (ABBV-400)","Unresectable Locally Advanced\u002FMetastatic CRC","ACTIVE_NOT_RECRUITING","2026-05-06",{"date":148,"type":134},"2026-05-11",{"date":150,"type":134},"2024-09-30",{"date":152,"type":153},"2027-12","ESTIMATED",{"name":5,"class":6},8]