Status:
SUSPENDED
A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
MDS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Main
- Newly diagnosed MDS subjects with higher risk.
- Age ≥ 18 years old.
- Eastern Cooperative Oncology Group score of 0-2.
- Adequate organ function.
- Subjects should take effective contraceptive measures.
- Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
- Main
Exclusion
- Subject who has transformed from MDS to AML.
- MDS subjects with lower risk.
- Subjects who have received chemotherapy.
- History of chronic hemolytic anemia
- Prior exposure to any anti-CD47 or anti-SIRPα agents.
- Subjects participating in another interventional clinical study.
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 4 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04511975
Start Date
August 24 2020
End Date
April 4 2022
Last Update
December 21 2020
Active Locations (3)
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1
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States, 20817
2
New Jersey Center for Cancer Research
Brick, New Jersey, United States, 08724
3
Gabrail Cancer Center
Canton, Ohio, United States, 44718