This is an open-label, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of IBI188 in combination with Azacitidine in newly diagnosed higher risk MDS patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
IBI188: 100 mg/mL, intravenous infusion once a week
Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
New Jersey Center for Cancer Research
Brick, New Jersey, United States
Gabrail Cancer Center
Canton, Ohio, United States
Adverse Events
Adverse events according to national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 or customized AE severity grading as defined in the protocol
Time frame: 28 days
Efficacy of IBI188 in combination with AZA
International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS
Time frame: 28 days
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