Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871334
• Other study ID #: TWP-101-11
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Melanoma
• Advanced Urothelial Carcinoma
• Carcinoma
• Carcinoma, Transitional Cell
• Melanoma

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