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

Shandong TheraWisdom Biopharma Co., Ltd.81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Malignancies

Interventions

TWP-102 injectionDRUG

IV infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of adverse events/serious adverse event related with TWP-102 injection

Time frame: From enrollment until 90 days after the last dose

Dose-limiting toxicity (DLT)

Time frame: From the first dose of study drug up to 3 weeks

Secondary Outcomes

Maximum measured plasma concentration (Cmax) of TWP-102 injection.

Time frame: From first dose until 90 days after the last dose

Time to maximum plasma concentration (Tmax) of TWP-102 injection.

Time frame: From first dose until 90 days after the last dose

Half-life (T1/2) of TWP-102 injection.

Time frame: From first dose until 90 days after the last dose

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.

Time frame: From first dose until 90 days after the last dose

Objective Response Rate (ORR)

Time frame: From first dose to disease progression or end of study, an average of 2 years

Duration of Response (DOR)

Time frame: From first dose to disease progression or end of study, an average of 2 years

Disease control rate (DCR)

Time frame: From first dose to disease progression or end of study, an average of 2 years

Central Contacts

Shengbin Ren

CONTACT

8021-60167707 shengbin.ren@therawisdom.com

Data from ClinicalTrials.gov

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