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Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4\u002FTrop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","Key Inclusion Criteria:\n\n* Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria:\n\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* Prior Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of allogenic stem cell or solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.","ALL","18 Years",{"count":174,"type":175},355,"ESTIMATED","INTERVENTIONAL",[178,179],"PHASE1","PHASE2","This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.",[182,183,184,185],"Solid Tumor Cancer","Locally Advanced","Metastatic Solid Tumors","Urothelial Cancer",[187,188,183,185],"Solid Tumors","Metastatic","2026-08-03",{"date":191,"type":192},"2026-08-05","ACTUAL",{"date":194,"type":192},"2025-10-02",{"date":196,"type":175},"2030-09",{"name":5,"class":6},13]