A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)
Trial Snapshot
- Phase
- Phase 1
- Status
- Suspended
- Enrollment
- 32
- Locations
- 3
- Primary Endpoint
- Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newly diagnosed MDS subjects with higher risk.
- •Age ≥ 18 years old.
- •Eastern Cooperative Oncology Group score of 0-
- •Adequate organ function.
- •Subjects should take effective contraceptive measures.
- •Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Exclusion Criteria
- •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.
Arms & Interventions
IBI188 + azacitidine
Participants will receive IBI188 in combination with azacitidine
Intervention: IBI188 (Drug)
IBI188 + azacitidine
Participants will receive IBI188 in combination with azacitidine
Intervention: Azacitidine (Drug)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 28 days
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
Efficacy of IBI188 in combination with AZA
Time Frame: 28 days
International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS
Secondary Outcomes
No secondary outcomes reported