Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
- Registration Number
- NCT04871334
- Lead Sponsor
- Shandong TheraWisdom Biopharma Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 76
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Cohort TWP-101 Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Dose Expansion Cohort TWP-101 Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Duration of Response (DOR) From first dose to disease progression, an average of 2 years 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 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. 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).
Trial Locations
- Locations (1)
Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China