A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS

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)

Status

Suspended

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04511975

Enrollment

Registered

2020-08-13

Start date

2020-08-24

Completion date

2022-04-04

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MDS

Keywords

MDS

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.

Interventions

DRUGIBI188

IBI188: 100 mg/mL, intravenous infusion once a week

DRUGAzacitidine

Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: 1. Newly diagnosed MDS subjects with higher risk. 2. Age ≥ 18 years old. 3. Eastern Cooperative Oncology Group score of 0-2. 4. Adequate organ function. 5. Subjects should take effective contraceptive measures. 6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures. Main

Exclusion criteria

1. Subject who has transformed from MDS to AML. 2. MDS subjects with lower risk. 3. Subjects who have received chemotherapy. 4. History of chronic hemolytic anemia 5. Prior exposure to any anti-CD47 or anti-SIRPα agents. 6. Subjects participating in another interventional clinical study.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	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	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026