Advanced Melanoma, Advanced Urothelial Carcinoma
Conditions
Brief 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.
Interventions
DRUGTWP-101
IV infusion Q2W for 4 weeks (28-day cycles)
Sponsors
Shandong TheraWisdom Biopharma Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLT) | 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. | From enrollment until 90 days after the last dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum plasma concentration (Tmax) of TWP-101. | From first dose until 90 days after the last dose | — |
| Half-life (T1/2) of TWP-101. | From first dose until 90 days after the last dose | — |
| Objective Response Rate (ORR) by RECIST Version 1.1 | From first dose to disease progression or end of study, an average of 2 years | — |
| Progression free survival (PFS). | From first dose to disease progression or end of study, an average of 2 years | — |
| Disease control rate (DCR). | From first dose to disease progression or end of study, an average of 2 years | — |
| Immunogenicity profile of TWP-101. | From first dose until 90 days after the last dose | 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). |
| Duration of Response (DOR) | From first dose to disease progression, an average of 2 years | — |
| Maximum measured plasma concentration (Cmax) of TWP-101. | From first dose until 90 days after the last dose | — |
Countries
China
Contacts
Primary ContactShengbin Ren
Outcome results
None listed