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Clinical Trial Summary

The main purpose of • To evaluate the safety, tolerability and pharmacokinetic characteristics of SIBP-03(Recombinant anti-HER3 humanized monoclonal antibody injection). A secondary purpose - Assess the immunogenicity of SIBP-03. Exploratory purpose - Explore potential biomarkers; - Preliminary evaluation of the antitumor efficacy of SIBP-03.

Clinical Trial Description

To evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of recombinant anti-HER3 humanized monoclonal antibody injection when treating the patients with advanced malignant solid tumors. This study is an open, multi-dose escalation and extension study of single and multiple dosing. This study was divided into two phases: the first phase was dose escalation phase, the second phase was joint expansion phase, in which the dose escalation phase was a single-center study, and the joint expansion phase was a multi-center study. Stage 1, dose escalation stage: Six dose groups of 2, 5, 10, 15, 20 and 40 mg/kg were planned, then exploring the most appropriate dose. The second stage, combined use extension stage: According to the preliminary data of drug safety, tolerance, pharmacokinetics and efficacy obtained in the dose escalation stage, combined with the clinical study results of similar drugs, 5mg/kg and 10mg/kg dose levels were selected to enter the combined extension stage and used in patients with advanced head and neck squamous cell carcinoma or with breast cancer. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05203601
Study type Interventional
Source Shanghai Institute Of Biological Products
Status Completed
Phase Phase 1
Start date November 26, 2020
Completion date December 6, 2022

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