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Clinical Trial Summary

The main purpose of this Phase I study is to access the safety and tolerability of Y150 at different dose levels. It is hoped to find out the recommended dose for Phase II/III.


Clinical Trial Description

This is a Phase I, open-label,dose-escalation trial in patients with relapsed or refractory multiple myeloma. There are two parts of the study: a dose-escalation part and a dose-expansion part. Dose escalation follows an accelerated design initially with 2 single subject cohorts (Cohorts 1-2) and switches to a classical 3+3 design (Cohorts 3-7). Dose-expansion means that at least 9 subjects (included subjects of the dose-escalation part) will be selected in 1 - 3 dose levels to focus on the pharmacokinetics (PK) / pharmacodynamic (PD) features and recommended dose for Phase II (RP2D). Additional purpose of the study is to find out whether the study drug has anti-tumor effects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05011097
Study type Interventional
Source Wuhan YZY Biopharma Co., Ltd.
Contact Mengwan Pei
Phone 86-27-82668988
Email peimengwan@yzybio.com
Status Recruiting
Phase Phase 1
Start date July 8, 2021
Completion date December 30, 2024

See also
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