Advanced Melanoma Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Shandong TheraWisdom Biopharma Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of dose-limiting toxicity (DLT) | From the first dose of study drug up to 4 weeks | ||
Primary | 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 | Objective Response Rate (ORR) by RECIST Version 1.1 | From first dose to disease progression or end of study, an average of 2 years | ||
Secondary | Duration of Response (DOR) | From first dose to disease progression, an average of 2 years | ||
Secondary | Disease control rate (DCR). | From first dose to disease progression or end of study, an average of 2 years | ||
Secondary | Progression free survival (PFS). | From first dose to disease progression or end of study, an average of 2 years | ||
Secondary | Maximum measured plasma concentration (Cmax) of TWP-101. | From first dose until 90 days after the last dose | ||
Secondary | Time to maximum plasma concentration (Tmax) of TWP-101. | From first dose until 90 days after the last dose | ||
Secondary | Half-life (T1/2) of TWP-101. | From first dose until 90 days after the last dose | ||
Secondary | Immunogenicity profile of TWP-101. | 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). | From first dose until 90 days after the last dose |
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