[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659374":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":49,"armGroups":57,"interventions":66,"overallOfficials":72,"centralContacts":76,"locations":49,"responsibleParty":82,"collaborators":49,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":49,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":49,"enrollmentInfo":93,"targetDuration":49,"studyType":96,"phases":97,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":125,"whyStopped":49,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":49},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":49},[9,13,16,18,20],{"measure":10,"description":11,"timeFrame":12},"Occurrence of dose-limiting toxicities (DLTs)","Part 1 (Dose Escalation)","Up to 21 days",{"measure":14,"description":11,"timeFrame":15},"Occurrence of Treatment Emergent Adverse Events (TEAEs)","Up to approximately 5 years",{"measure":17,"description":11,"timeFrame":15},"Occurrence of Serious Adverse Events (SAEs)",{"measure":19,"description":11,"timeFrame":15},"Occurrence of adverse event of special interests (AESIs)",{"measure":21,"description":22,"timeFrame":15},"Objective response (OR) (investigator assessed) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1","Part 2 (Dose Expansion)",[24,26,29,31,33,35,37,39,41,43,45,47],{"measure":25,"description":11,"timeFrame":15},"Objective response (investigator assessed) per RECIST 1.1",{"measure":27,"description":28,"timeFrame":15},"Concentrations of ADC","Part 1 (Dose Escalation) and Part 2 (Dose Expansion)",{"measure":30,"description":28,"timeFrame":15},"Concentrations of total antibody",{"measure":32,"description":28,"timeFrame":15},"Concentrations of payload (ProDXd and DXd)",{"measure":34,"description":28,"timeFrame":15},"Occurrence of Anti-Drug Antibodies (ADA) against REGN13089-M404-M2980",{"measure":36,"description":28,"timeFrame":15},"Magnitude of ADA against REGN13089-M404-M2980",{"measure":38,"description":22,"timeFrame":15},"Duration of response per RECIST 1.1",{"measure":40,"description":22,"timeFrame":15},"Time to response per RECIST 1.1",{"measure":42,"description":22,"timeFrame":15},"Progression-free survival per RECIST 1.1",{"measure":44,"description":22,"timeFrame":15},"Overall survival",{"measure":46,"description":22,"timeFrame":15},"Occurrence of TEAEs considered clinically significant",{"measure":48,"description":22,"timeFrame":15},"Laboratory abnormalities considered clinically significant",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":49,"timePerspective":49,"maskingInfo":55},"RANDOMIZED","SEQUENTIAL","Part 1: Sequential assignment Part 2: Randomized assignment","TREATMENT",{"masking":56,"maskingDescription":49,"whoMasked":49},"NONE",[58,63],{"label":59,"type":60,"description":49,"interventionNames":61},"Part 1: Dose Escalation","EXPERIMENTAL",[62],"Drug: REGN13089-M404-M2980",{"label":64,"type":60,"description":49,"interventionNames":65},"Part 2: Dose Expansion",[62],[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":49},"DRUG","REGN13089-M404-M2980","Administered per the protocol",[59,64],[73],{"name":74,"affiliation":5,"role":75},"Clinical Trial Management","STUDY_DIRECTOR",[77],{"name":78,"role":79,"phone":80,"phoneExt":49,"email":81},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",{"type":83,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100659374","phase-1-safety-and-efficacy-study-in-adults-with-advanced-solid-tumors-receiving-regn13089-m404-m2980-an-antibody-drug-conjugate-that-targets-met-protein-on-tumors-100659374",false,"NCT07863024","Safety and Efficacy Study in Adults With Advanced Solid Tumors Receiving REGN13089-M404-M2980, an Antibody-drug Conjugate That Targets MET Protein on Tumors","A Phase 1\u002F2 Study of REGN13089-M404-M2980, a MET-targeting Antibody-Drug Conjugate in Adult Participants With Previously Treated Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Histologically confirmed cancer (non-small cell lung cancer (epidermal growth factor receptor mutant type or epidermal growth factor receptor mutant type), colorectal cancer, gastric\u002Fgastroesophageal junction cancer, uveal melanoma, papillary renal cell carcinoma, or clear cell renal cell carcinoma) that is at an advanced stage as described in the protocol\n2. Participants must not be candidates for curative surgery or radiation\n3. Participants are required to have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease, or intolerance of the therapy as described in the protocol\n4. Willing to provide tumor tissue; archival or fresh tumor tissue will be accepted as described in the protocol\n5. At least 1 lesion that is measurable by RECIST 1.1. Tumor lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate organ and bone marrow function as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device as described in the protocol\n2. Has received radiation therapy within the 28 days prior to first administration of study intervention. Palliative stereotactic radiation therapy without a thoracic or abdominal field is allowed with a washout period of 14 days from first administration of study intervention.\n3. Has undergone major surgery within the 14 days prior to first administration of study intervention\n4. Has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities resulting from prior therapy as described in the protocol\n5. Has a history of interstitial lung disease (eg, idiopathic pulmonary fibrosis, etc) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management or has imaging consistent with these diseases during the screening period. A history of radiation pneumonitis is permitted as long as pneumonitis resolved ≥6 months prior to enrollment.\n6. Has received prior treatment with an antibody-drug conjugate (ADC) that includes a topoisomerase payload\n7. Known active or untreated brain metastases or spinal cord compression. Participants are eligible if central nervous system (CNS) metastases are adequately treated, and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment.\n\nNote: Other protocol defined inclusion\u002F exclusion criteria apply","ALL","18 Years",{"count":94,"type":95},320,"ESTIMATED","INTERVENTIONAL",[98,99],"PHASE1","PHASE2","This study will test a Regeneron drug called REGN13089-M404-M2980 (\"study drug\") to see if it can help treat previously treated, advanced solid tumors (tumors that have grown and spread to different areas of the body).\n\nThe study is focused on advanced cancers that have more of a protein called mesenchymal epithelial transition factor (MET) on the surface of their cells than usual. The study drug works by binding to MET on tumor cells and delivering chemotherapy directly into those cells. This may stop growth of the cancer cells and kill only the cancer cells and not the other normal tissues in your body. However, some of the chemotherapy may still affect the normal cells and side effects can still occur.\n\nThe study is looking at:\n\n* What side effects the study drug might cause\n* How well the study drug works\n* How much of the study drug is in the blood at different times\n* If the body reacts to the study drug, in a way that may cause the study drug to not work as well\n* What is the best dose of the study drug for treating previously treated, advanced solid tumors",[102],"Advanced Solid Tumors",[104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"ADC","Antibody-drug conjugate","Advanced cancer","Advanced solid malignancy","Clear cell renal cell carcinoma","Colorectal cancer","First-in-human","FIH","Gastric cancer","Gastroesophageal junction cancer","MET","METxMET antibody-drug conjugate","Metastatic","Metastatic solid tumor","Non-small cell lung cancer","NSCLC","Papillary renal cell carcinoma","Solid neoplasm","Unresectable","Unresectable solid tumor","Uveal melanoma","NOT_YET_RECRUITING","2026-10-02",{"date":128,"type":129},"2026-10-07","ACTUAL",{"date":131,"type":95},"2026-11-23",{"date":133,"type":95},"2031-03-10",{"name":5,"class":6}]