[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612872":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":42,"centralContacts":47,"locations":56,"responsibleParty":79,"collaborators":41,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":41,"enrollmentInfo":91,"targetDuration":41,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":58,"whyStopped":41,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"UNICANCER","OTHER",[8,14,18,22],{"label":9,"type":6,"description":10,"interventionNames":11},"T-DXd (trastuzumab deruxtecan)","Standard of care T-DXd indication",[12,13],"Procedure: Biological samples collection","Behavioral: questionnaires to collect patient reported outcomes",{"label":15,"type":6,"description":16,"interventionNames":17},"T-DM1 (trastuzumab emtansine)","Standard of care T-DM1 indication",[12,13],{"label":19,"type":6,"description":20,"interventionNames":21},"SG (sacituzumab govitecan)","Standard of care SG indication",[12,13],{"label":23,"type":6,"description":24,"interventionNames":25},"EV (enfortumab vedotin)","Standard of care EV indication",[12,13],[27,36],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Biological samples collection","Biological samples collection (tumor tissue, blood, sputum) before initiation of treatment, during treatment, and at treatment discontinuation.",[23,19,15,9],[33,34,35],"Blood sample collection","Sputum sample collection","Tumor tissue sample collection",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BEHAVIORAL","questionnaires to collect patient reported outcomes","QLQ-C30, QLQ-FA12, HADS, EQ-5D 5L",[23,19,15,9],null,[43],{"name":44,"affiliation":45,"role":46},"Barbara Pistilli, MD, PhD","Gustave Roussy Cancer Center","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":41,"email":52},"Marjorie Mauduit","CONTACT","+33 6 30481792","m-mauduit@unicancer.fr",{"name":54,"role":50,"phone":41,"phoneExt":41,"email":55},"Jérôme Lemonnier","j-lemonnier@unicancer.fr",[57],{"facility":45,"status":58,"city":59,"state":41,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Villejuif","94805","France","FR",{"type":64,"coordinates":65},"Point",[66,67],2.35992,48.7939,{"lat":67,"lon":66},[70,74,78],{"name":71,"role":50,"phone":72,"phoneExt":41,"email":73},"Barbara PISTILLI, MD","+33 (0)1 42 11 61 62","barbara.pistilli@gustaveroussy.fr",{"name":75,"role":50,"phone":76,"phoneExt":41,"email":77},"Noemie CORCOS, PhD","+ 33 (0) 1 42 11 51 58","Noemie.CORCOS@gustaveroussy.fr",{"name":71,"role":46,"phone":41,"phoneExt":41,"email":41},{"type":80,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100612872","phase-2-optimal-methods-to-characterize-adc-resistance-in-solid-tumors-and-identify-clinically-useful-biomarkers-100612872",false,"NCT07259226","Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers","International Multicenter Multicohort Open-label Phase II Trial Aiming to Define Optimal Methods for Predicting Response\u002FResistance to Antibody-drug Conjugates in Patients With Solid Tumors Treated According to Current Standard Indications.","OASIS","Inclusion Criteria:\n\n1. Patients must have signed a written informed consent form prior to any trial specific procedures;\n2. Patients must be ≥18 years old;\n3. Histologically confirmed or radiologically documented unresectable locally advanced or metastatic cancer (Breast, Urothelial, Non small Cell Lung or Gastric) with an indication to receive an Antibody-Drug Conjugate (ADC) approved or accessible through an early access program;\n4. Patients must have at least 2 tumor lesions (primary tumor can be included): at least one measurable tumor lesion for tumor evaluation according to response evaluation criteria in solid tumors (RECIST) V1.1 and at least one tumor lesion other than bone and brain for biopsy;\n5. Patients must have a metastatic or locally advanced tumor site easily accessible to biopsy (with exception of bone and brain metastasis) and must have agreed to perform pretreatment and post-treatment biopsies; an archival pre-treatment biopsy may be used if it was collected within one month of enrolment, if no anticancer therapy was administered after the biopsy and if sufficient material is available for research;\n6. Life expectancy must be ≥12 weeks according to the discretion of the investigator;\n7. ECOG performance status ≤ 2;\n8. Patients must have adequate hematologic and organ function, compatible with ADC administration, as per drug-specific recommendations;\n9. Women of childbearing potential and male patient must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment for women and up to 4 months for men;\n10. Patients must be affiliated to a social security system (or equivalent);\n11. Patients must be willing and able to comply with the protocol for the duration of the trial;\n12. Patients must consent to the use of their collected tumor specimen, as well as, blood samples as detailed in the protocol for future scientific research, which includes but is not limited to DNA, RNA, and protein-based biomarker analysis.\n\nExclusion Criteria:\n\n1. Patients treated with an antibody drug conjugate in a curative setting;\n2. Patients who did not consent to sample use;\n3. Presence of another progressive pathology with short-term life-threatening prognosis;\n4. Patients undergoing concurrent treatment for a malignancy or hematologic disorder distinct from the indication for which the ADC is being administered.\n5. Patients with inadequate washout period prior to Cycle 1 Day 1, defined as:\n\n   * Whole brain radiation therapy \\\u003C14 days or stereotactic brain radiation therapy \\\u003C7 days.\n   * Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) (including another ADC) from a previous cancer treatment regimen or clinical study (other than epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI)), \\\u003C14 days or 5 half-lives, whichever is longer.\n   * Immune checkpoint inhibitor therapy \\\u003C21 days.\n   * Hormonal therapy \\\u003C21 days.\n   * Major surgery (excluding placement of vascular access) \\\u003C28 days.\n   * Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \\\u003C28 days or palliative radiation therapy \\\u003C14 days.\n6. Female participant who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 90 days after the final administration of study treatment;\n7. Person deprived of their liberty or under protective custody or guardianship.","ALL","18 Years",{"count":92,"type":93},400,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","International study that will evaluate the association of prespecified biomarkers with resistance to Antibody-drug conjugates (ADCs), a type of targeted cancer treatment currently used in clinical practice for treating different tumor types.",[99,100,101,102],"Advanced Breast Cancer","Advanced Gastric Cancer","Advanced Urothelial Cancer","Advanced Non Small Cell Lung Cancer (NSCLC)",[104,105],"ADC","resistance","2025-11-20",{"date":108,"type":109},"2025-12-02","ACTUAL",{"date":111,"type":109},"2025-11-14",{"date":113,"type":93},"2030-11-01",{"name":5,"class":6},1]