Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.

Advanced Malignancies Clinical Trial

Official title:

A Multi-center, Phase I, Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05024305
• Other study ID #: TWP-102-11
• Status: Recruiting
• Phase: Phase 1
• Start date: March 8, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 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 I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments;
• At least 1 measurable lesion.
• ECOG score 0 or 1;
• Life expectancy of = 3 months;

Exclusion Criteria:

• Known hypersensitivity to any ingredient of TWP-102;
• Receiving any anti-cancer drugs within 4 weeks;
• History of serious systemic diseases;
• History of serious autoimmune diseases;
• Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade > 1 severity that is related to prior anti-cancer therapy. (except alopecia)
• Pregnancy or lactating women.

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

Drug:
• TWP-102 injection
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 adverse events/serious adverse event related with TWP-102 injection		From enrollment until 90 days after the last dose
Primary	Dose-limiting toxicity (DLT)		From the first dose of study drug up to 3 weeks
Secondary	Maximum measured plasma concentration (Cmax) of TWP-102 injection.		From first dose until 90 days after the last dose
Secondary	Time to maximum plasma concentration (Tmax) of TWP-102 injection.		From first dose until 90 days after the last dose
Secondary	Half-life (T1/2) of TWP-102 injection.		From first dose until 90 days after the last dose
Secondary	Immunogenicity profile of TWP-102 injection.	Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.	From first dose until 90 days after the last dose
Secondary	Objective Response Rate (ORR)		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 or end of study, 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