Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.

Inclusion Criteria:

• Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments
• ECOG score 0 or 1;
• Part B: At least 1 measurable lesion according to RECIST 1.1

Exclusion Criteria:

• Known hypersensitivity to any ingredient of TWP-101;
• Receiving any anti-cancer drugs;
• History of serious systemic diseases;
• History of serious autoimmune diseases;
• Pregnancy or lactating women.