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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
IV infusion Q2W for 4 weeks (28-day cycles)
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of dose-limiting toxicity (DLT)
Time frame: From the first dose of study drug up to 4 weeks
Incidence of adverse events and serious adverse event (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)) and irAE.
Time frame: From enrollment until 90 days after the last dose
Objective Response Rate (ORR) by RECIST Version 1.1
Time frame: From first dose to disease progression or end of study, an average of 2 years
Duration of Response (DOR)
Time frame: From first dose to disease progression, an average of 2 years
Disease control rate (DCR).
Time frame: From first dose to disease progression or end of study, an average of 2 years
Progression free survival (PFS).
Time frame: From first dose to disease progression or end of study, an average of 2 years
Maximum measured plasma concentration (Cmax) of TWP-101.
Time frame: From first dose until 90 days after the last dose
Time to maximum plasma concentration (Tmax) of TWP-101.
Time frame: From first dose until 90 days after the last dose
Half-life (T1/2) of TWP-101.
Time frame: From first dose until 90 days after the last dose
Immunogenicity profile of TWP-101.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies by meso scale discovery(MSD).
Time frame: From first dose until 90 days after the last dose