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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohort | Experimental | Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. |
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| Dose Expansion Cohort | Experimental | Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TWP-101 | Drug | IV infusion Q2W for 4 weeks (28-day cycles) |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by RECIST Version 1.1 | From first dose to disease progression or end of study, an average of 2 years | |
| Duration of Response (DOR) | From first dose to disease progression, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengbin Ren | Contact | 8021-60167707 | shengbin.ren@therawisdom.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Disease control rate (DCR). | 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 |
| Maximum measured plasma concentration (Cmax) of TWP-101. | From first dose until 90 days after the last dose |
| 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 |
| 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 |