Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS

Study Overview
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Brief Summary
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The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome

Official Title
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A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome

Conditions
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Myelodysplastic Syndromes

Intervention / Treatment
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* Drug: IBI188+azacitidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MDS subjects with higher risk; Age ≥ 18 years old; Eastern Cooperative Oncology Group score of 0 1; Not suitable for or refuse to receive HSCT; Newly diagnosed MDS subjects; 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. Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN. MDS subjects with lower risk. Subjects who have received chemotherapy. Prior exposure to any anti-CD47 or anti-SIRPα agents. Subjects participating in another interventional clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI188+azacitidine<br> | Drug: IBI188+azacitidine<br>* Escalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS) | 24 months | 
| Complete response rate (CR) and duration of complete response (DoCR) | Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the central laboratory. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate (CR) and duration of complete response (DoCR) | Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the investigators; | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS