The Safety and Efficacy of TWP-101 in Patients With Advanced Solid Tumor

Advanced Solid Tumor Clinical Trial

Official title:

A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety and Efficacy of TWP-101 in Patients With Advanced Solid Tumor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04871347
• Other study ID #: TWP-101-12
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 30, 2021
• Est. completion date: December 31, 2023

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 is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety and efficacy of TWP-101 in patients with advanced solid tumor. 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: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically or cytologically confirmed advanced solid tumor that failed, couldn't tolerate or refused standard treatments;

• ECOG score 0 or 1;

• 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 within 4 weeks;

• History of serious systemic diseases;

• History of serious autoimmune diseases;

• Pregnancy or lactating women.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• TWP-101
IV infusion

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang

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