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Clinical Trial Summary

It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors


Clinical Trial Description

This is a phase Ⅰ/Ⅱ, multicenter, open-label, first-in-human study in patients with advanced solid tumors. During the phase Ⅰ study, the safety and tolerability of HB0036 will be evaluated in patients with advanced solid tumors. In the phase Ⅱ study, the safety and efficacy of HB0036 at the RP2D will be evaluated in cohorts of patients with NSCLC and/or other solid tumors. A Safety Review Committee (SRC) will be established throughout the study period, consisting of the principal investigator, representatives of the contract research organization (CRO) (medical inspectors and other relevant personnel), and the Sponsor's medical monitor. The SRC will evaluate safety data based on the study process. The SRC may recommend extended doses, possible changes in the frequency of administration, and extended tumor types for safety reasons based on existing studies prior to starting the phase II study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05417321
Study type Interventional
Source Shanghai Huaota Biopharmaceutical Co., Ltd.
Contact Jingjing Wang, Master
Phone 021-51320053
Email jingjing.wang@huaota.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 25, 2022
Completion date August 1, 2024

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