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Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab

Solid Tumors Clinical Trial

Official title:
An Open Phase I Study to Evaluate the Safety, Tolerability, PK / PD, and Initial Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced Melanoma and Other Solid Tumors

Clinical Trial Summary

HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.

Clinical Trial Description

An open-label Phase 1 study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors. The study is composed of two part, part 1 will be approximately 31subjects and Part 2 will be approximately 30 subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04727164
Study type Interventional
Source Harbour BioMed (Guangzhou) Co. Ltd.
Contact Wangnan ZHOU, Master
Phone +13810905733
Email wangnan.zhou@harbourbiomed.com
Status Not yet recruiting
Phase Phase 1
Start date February 28, 2021
Completion date November 2023
View Details
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