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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04871334
Other study ID # TWP-101-11
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 7, 2021
Est. completion date December 31, 2022

Study information

Verified date May 2021
Source Shandong TheraWisdom Biopharma Co., Ltd.
Contact Shengbin Ren
Phone 8021-60167707
Email shengbin.ren@therawisdom.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
TWP-101
IV infusion Q2W for 4 weeks (28-day cycles)

Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shandong TheraWisdom Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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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