Nctid:
NCT06613100
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D000005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000011469", "term"=>"Prostatic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M2853", "name"=>"Immunomodulating Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-31", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2029-09-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-03", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-05-27", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of Participants who Experienced Treatment-emergent Adverse Events", "timeFrame"=>"Up to 42 months", "description"=>"Inclusive of adverse events, serious adverse events, and changes in vital signs and clinical laboratory tests."}, {"measure"=>"Number of Participants who Experienced Treatment-related Adverse Events", "timeFrame"=>"Up to 12 weeks post radical prostatectomy (RP)"}, {"measure"=>"Number of Participants who Received Radical Prostatectomy After Completing Xaluritamig Treatment", "timeFrame"=>"Up to 4 weeks after completing xaluritamig therapy, a maximum of 12 weeks"}, {"measure"=>"Number of Participants who Experienced Complications of Radical Prostatectomy According to Clavien-Dindo Classification", "timeFrame"=>"Up to approximately 90 days after completion of the radical prostatectomy surgery, a maximum of 12 weeks"}], "secondaryOutcomes"=>[{"measure"=>"Change in Prostate-specific Antigen (PSA) Levels from Baseline to End of Xaluritamig Treatment", "timeFrame"=>"Up to 42 months"}, {"measure"=>"Prostate Imaging-Reporting and Data System (PI-RADS) Score", "timeFrame"=>"Baseline and after 8 weeks of neoadjuvant therapy"}, {"measure"=>"Pathological Complete Response (pCR) Following Radical Prostatectomy", "timeFrame"=>"After 8 weeks of neoadjuvant therapy + RP"}, {"measure"=>"Minimal Residual Disease (MRD)", "timeFrame"=>"After 8 weeks of neoadjuvant therapy + RP"}, {"measure"=>"Number of Participants who Rise to PSA ≥ 0.2 ng/mL Post-radical Prostatectomy", "timeFrame"=>"Up to 42 months"}, {"measure"=>"Time to PSA Rise ≥ 0.2 ng/mL Post-radical Prostatectomy", "timeFrame"=>"Up to 42 months"}, {"measure"=>"Undetectable PSA at SFU", "timeFrame"=>"19 weeks"}, {"measure"=>"Prostate Specific Antigen (PSA)-Free Survival", "timeFrame"=>"Up to 42 months"}, {"measure"=>"Maximum Serum Concentration (Cmax) of Xaluritamig", "timeFrame"=>"Up to 30 days after the last dose of neoadjuvant therapy"}, {"measure"=>"Time to Maximum Concentration (Tmax) of Xaluritamig", "timeFrame"=>"Up to 30 days after the last dose of neoadjuvant therapy"}, {"measure"=>"Area Under the Concentration Time Curve (AUC) Over the Dosing Interval", "timeFrame"=>"Up to 30 days after the last dose of neoadjuvant therapy"}, {"measure"=>"Accumulation Following Multiple Dosing", "timeFrame"=>"Up to 30 days after the last dose of neoadjuvant therapy"}, {"measure"=>"Half-life (t1/2) of Xaluritamig", "timeFrame"=>"Up to 30 days after the last dose of neoadjuvant therapy"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Xaluritamig", "AMG509", "Localized Prostate Cancer", "Prostate Cancer", "Neoadjuvant Therapy", "Immunotherapy", "T-Cell Engager", "STEAP1"], "conditions"=>["Prostate Cancer"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"http://www.amgentrials.com", "label"=>"AmgenTrials clinical trials website"}]}, "descriptionModule"=>{"briefSummary"=>"The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered in the neoadjuvant setting followed by radical prostatectomy and to evaluate the feasibility and safety of a radical prostatectomy following xaluritamig administered in the neoadjuvant setting."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "genderBased"=>true, "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nSubjects are eligible to be included in the study only if all the following criteria apply:\n\n* Subjects planned to undergo radical prostatectomy.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. Intermediate- or high-risk localized prostate cancer, defined as:\n* Gleason score of 4+3 or higher AND iPSA \\>10 OR\n* Clinically advanced (cT3) on MRI imaging obtained within 3 months prior to screening AND/OR\n* Positive locoregional lymph nodes as detected by PSMA-PET scans OR equal or ≤ 5 local lymph nodes on MRI can be enrolled.\n* Subjects must have undergone a gallium-68 prostate-specific membrane antigen (68Ga-PSMA-11) or a piflufolastat F 18 PET (CT or MRI) scan within 3 months prior to screening as part of the SOC.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\nExclusion Criteria:\n\nSubjects are excluded from the study if any of the following criteria apply:\n\n* Prior treatment for subject's prostate cancer.\n* Any evidence of metastases outside of the surgical resection field identified by conventional imaging or PSMA-PET scans.\n* Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.\n* Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment:\n* Subject has known active infection requiring antibiotic treatment. Upon completion of antibiotics and resolution of symptoms, the subject may be considered eligible for the study from an infection standpoint.\n* History of arterial or venous thrombosis or other diseases requiring permanent anticoagulation (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis):\n* Patients requiring anticoagulation due to atrial fibrillation may be allowed if they can safely stop the anticoagulation for the perisurgical timeframe.\n* Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association ≥ class II) within 12 months of first dose of xaluritamig with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement more than 6 months prior to first dose of xaluritamig.\n* Requirement for chronic systemic corticosteroid therapy\n* Currently receiving treatment in another investigational device or drug study, or less than 4 weeks (since ending treatment on another investigational device or drug study\\[ies\\]). Other investigational procedures and participation in observational research studies while participating in this study are excluded with the exception of investigational scans."}, "identificationModule"=>{"nctId"=>"NCT06613100", "briefTitle"=>"Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Amgen"}, "officialTitle"=>"A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, and Feasibility of Neoadjuvant Xaluritamig Therapy Prior to Radical Prostatectomy in Subjects With Newly Diagnosed Localized Intermediate or High-Risk Prostate Cancer", "orgStudyIdInfo"=>{"id"=>"20230237"}, "secondaryIdInfos"=>[{"id"=>"2024-511965-13", "type"=>"OTHER", "domain"=>"EU CT Number"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Xaluritamig", "description"=>"Xaluritamig will be administered prior to radical prostatectomy.", "interventionNames"=>["Drug: Xaluritamig"]}], "interventions"=>[{"name"=>"Xaluritamig", "type"=>"DRUG", "otherNames"=>["AMG 509"], "description"=>"Intravenous (IV) infusion", "armGroupLabels"=>["Xaluritamig"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Amgen Call Center", "role"=>"CONTACT", "email"=>"medinfo@amgen.com", "phone"=>"866-572-6436"}], "overallOfficials"=>[{"name"=>"MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Amgen"}]}, "ipdSharingStatementModule"=>{"url"=>"http://www.amgen.com/datasharing", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF", "CSR"], "timeFrame"=>"Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.", "ipdSharing"=>"YES", "description"=>"De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.", "accessCriteria"=>"Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Amgen", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
