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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong TheraWisdom Biopharma Co., Ltd.

Criteria

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.