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.
This is a Phase I, open-labeldose-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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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