[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-urothelial-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-urothelial-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100630157","phase-1-study-of-gb-4362-with-enfortumab-vedotin-and-pembrolizumab-for-advanced-urothelial-cancer-100630157",false,"NCT07484022","Study of GB-4362 With Enfortumab Vedotin and Pembrolizumab for Advanced Urothelial Cancer","A Phase 1, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GB-4362 Administered With Enfortumab Vedotin and Pembrolizumab in Participants With Advanced Urothelial Cancer","Inclusion Criteria\n\n* Planned to receive standard-of-care treatment with enfortumab vedotin (EV) (starting dose 1.25 mg\u002Fkg) in combination with pembrolizumab for locally advanced or metastatic urothelial cancer.\n* Age ≥18 years.\n* ECOG Performance Status score of 0 or 1 (ECOG 2 excluded in Dose Escalation but allowed in Dose Expansion).\n* Weight ≥50 kg at screening.\n* Life expectancy ≥3 months, as determined by the investigator.\n* Participants must provide written informed consent before any study-related activities are carried out and must be able to understand the nature and purpose of the study, including potential risks and adverse effects.\n* Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria\n\n* Previously received enfortumab vedotin (EV) or other MMAE-based antibody-drug conjugates (ADCs).\n* Received anti-cancer treatment with chemotherapy, biologics, or investigational agents within 4 weeks before the first dose of EV\u002Fpembrolizumab.\n* Uncontrolled diabetes.\n* Active CNS metastases. Participants with treated CNS metastases are permitted if all of the following criteria are met:\n* CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.\n* The participant is on a stable dose of ≤10 mg\u002Fday of prednisone or equivalent for at least 2 weeks (if requiring steroid treatment).\n* The participant does not have leptomeningeal disease.\n* Ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery) that has not resolved to Grade ≤1 or returned to baseline.\n* History of a severe (Grade ≥3) allergic or infusion-related reaction to any monoclonal antibody.\n* Another underlying medical condition that, in the opinion of the investigator, would impair the ability of the participant to receive or tolerate the planned treatment and follow-up.\n* Known psychiatric or substance abuse disorders that would interfere with cooperating with study requirements","ALL","18 Years",{"count":19,"type":20},37,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of an investigational drug called GB-4362 when it is given together with enfortumab vedotin and pembrolizumab in adults with advanced or metastatic urothelial cancer. GB-4362 is a monoclonal antibody designed to bind and neutralize free monomethyl auristatin E (MMAE), a chemotherapy payload released from enfortumab vedotin that is associated with side effects such as peripheral neuropathy.",[26,27],"Advanced Urothelial Cancer","Metastatic Urothelial Carcinoma",[29,30,31,32,33,34,35,36,37],"GB-4362","Enfortumab Vedotin","Pembrolizumab","Peripheral Neuropathy","Antibody-Drug Conjugate","MMAE","Phase 1 Oncology","Dose Escalation","Dose Expansion","RECRUITING","2026-06-17",{"date":41,"type":42},"2026-06-18","ACTUAL",{"date":44,"type":20},"2026-06",{"date":46,"type":20},"2027-12",{"name":48,"class":49},"Generate Biomedicines","INDUSTRY",10,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100635114","acupuncture-and-exercise-for-ev-pembro-induced-peripheral-neuropathy-100635114","NCT07548476","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)","ACE","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Diagnosed with pathologically proven advanced or metastatic urothelial cancer (mUC)\n* Planning to receive treatment with EV-Pembro or have received up to two cycles of EV-Pembro treatment with enrollment occurring prior to the start of the third cycle\n* Self-reported ability to walk for 6 minutes and\u002For 2 blocks\n* Deemed acceptable for exercise by their treating provider\n* Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise\u002Fweek, as assessed by the Godin Leisure-Time Exercise Questionnaire\n* Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments\n* Eligible per verbally administered Physical Activity Readiness Questionnaire (PAR-Q+)\n* Referrals to physical therapy are allowed during the study if necessary; and\n* Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study.\n* Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin\n\nExclusion Criteria:\n\n* History of peripheral neuropathy prior to EV-Pembro initiation\n* Patients with a pacemaker or other electronically charged medical device; or\n* Participate in more than 60 minutes of moderate or vigorous structured exercise\u002Fweek\n\nInvestigators will not include the following special populations:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers \\\u003C 18 years)\n* Pregnant women\n* Prisoners",{"count":60,"type":20},50,[62],"NA","The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with metastatic bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).\n\nThe names of the two study groups in this research study are:\n\n* Acupuncture + Virtual Exercise (AVE)\n* Virtual Exercise Only (VE)",[65,32,26,66],"Metastatic Bladder Cancer","Metastatic Urothelial Cancer",[68,69,70],"Enfortumab Vedotin-Induced Neuropathy","Pembrolizumab-Induced Neuropathy","mUC","NOT_YET_RECRUITING","2026-04-28",{"date":74,"type":42},"2026-05-04",{"date":76,"type":20},"2026-10-02",{"date":78,"type":20},"2027-03-02",{"name":80,"class":81},"Dana-Farber Cancer Institute","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":82},"100612872","phase-2-optimal-methods-to-characterize-adc-resistance-in-solid-tumors-and-identify-clinically-useful-biomarkers-100612872","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.",{"count":92,"type":20},400,[94],"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.",[97,98,26,99],"Advanced Breast Cancer","Advanced Gastric Cancer","Advanced Non Small Cell Lung Cancer (NSCLC)",[101,102],"ADC","resistance","2025-11-20",{"date":105,"type":42},"2025-12-02",{"date":107,"type":42},"2025-11-14",{"date":109,"type":20},"2030-11-01",{"name":111,"class":81},"UNICANCER"]