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A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combine With Toripalimab in Patients With Advanced HCC and Other Solid Tumors

Solid Tumors Clinical Trial

Official title:
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced HCC and Other Solid Tumors

Clinical Trial Summary

This is an open-label, multi-center phase 1 study. The trial, consisting of Part 1 dose confirmation and Part 2 dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with Toripalimab in patients with advanced HCC and other solid tumors.

Clinical Trial Description

subjects will be treated with HBM4003 in combination with Toripalimab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first. This trial consists of : - A screening period: 28 days - A treatment period: - Part 1 dose confirmation study - Part 2 dose expansion study - A post-treatment follow-up period, including - A safety follow-up period: 28 days after the last dose of study drug; - Post-treatment follow-up visit: day 84 after the last dose of study drug; - Survival follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05149027
Study type Interventional
Source Harbour BioMed (Guangzhou) Co. Ltd.
Contact Xiaoying Wang
Phone +18201936643
Email hbm4003public@harbourbiomed.com
Status Not yet recruiting
Phase Phase 1
Start date December 20, 2021
Completion date May 30, 2024
View Details
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