This study is aimed to evaluate the efficacy, safety, immunogenicity and pharmkinetics, pharmacodynamics of 6MW3211 as monotherapy and in combination with AZA or AZA plus VEN in patients with AML/MDS.
This study is a phase I/II study to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of 6MW3211 monotherapy or combined with AZA or AZA plus VEN in patients with AML and MDS. There will be 2 parts of this study. The phase Ib is about monotherapy of 6MW3211 and Phase II is designed to evaluate the safety and efficacy of 6MW3211 combined with AZA or AZA plus VEN in patients with relapse/refractory and newly diagnosed AML and MDS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
phaseI: 6MW3211 will be administered in 30mg/kg and 45mg/kg intravenously once every 2 weeks; phaseII: 6MW3211 will be administered in 45mg/kg intravenously in both 2 cohorts.AZA will be administered in 75mg/m2 by subcoutaneous injection in cohort 1 as well as cohort 2 from Day1-Day7 every 28-day cycle. VEN will be administered orally with dose escalation to 400mg daily every cycle.
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGCCR
Compound complete response rate
Time frame: 1 year
ORR
Objective Response Rate
Time frame: 1 year
phase II: safety
to evaluate the percentage of participants with adverse events and serious adverse events of 6MW3211 combination therapy in AML and MDS
Time frame: Up to 28 days post last dose
AE
All the adverse events
Time frame: Up to 28 days post last dose
DoCR
Duration of complete response
Time frame: 1 year
RFS
Relapse-free survival
Time frame: 1 year
EFS
Event-free survival
Time frame: 1 year
OS
Overall survival
Time frame: 1 year
PK Parameter
The area under the curve (AUC)
Time frame: 1 year
Cmax
Maximum concentration
Time frame: 1 year
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Tmax
Time at which maximum concentration
Time frame: 1 year
T1/2
The half life
Time frame: 1 year