A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma

Inclusion criteria

• Competent to comprehend, sign, and date an informed consent form.
• Male or female subjects must be age 18 or older.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subjects must have histologically documented, unresectable locally advanced or
• Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.
• An archival tumor tissue sample or a fresh tissue sample should be provided.
• Subjects must have measurable disease according to RECIST (version 1.1).

Exclusion criteria

• Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
• Subjects who have previously received TOPO1-based ADCs.
• Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.
• Subjects who have received radiotherapy within 14 days , or chest radiotherapy > 30Gy within 6 months prior to the first dose of study drug.
• Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.
• Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.
• Subjects who have known or suspected interstitial pneumonitis.
• Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.
• Subjects who have any active, known or suspected autoimmune diseases.
• Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.
• Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.