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Navigator","434-982-0539","uvacancertrials@uva.com",{"type":179,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":190,"type":191},37,"ESTIMATED","INTERVENTIONAL",[194],"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. 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