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

Innovent Biologics (Suzhou) Co. Ltd.120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Myelodysplastic Syndromes

Interventions

IBI188+azacitidineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. MDS subjects with higher risk; 2. Age ≥ 18 years old; 3. Eastern Cooperative Oncology Group score of 0\~1; 4. Not suitable for or refuse to receive HSCT; 5. Newly diagnosed MDS subjects; 6. Adequate organ function; 7. Subjects should take effective contraceptive measures 8. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures. Exclusion Criteria: 1. Subject who has transformed from MDS to AML. 2. Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN. 3. MDS subjects with lower risk. 4. Subjects who have received chemotherapy. 5. Prior exposure to any anti-CD47 or anti-SIRPα agents. 6. Subjects participating in another interventional clinical study.

Locations (1)

Blood Diseases Hospital Chinese Academy Of Medical Science

Tianjin, China

Outcomes

Primary Outcomes

Safety and tolerability

To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)

Time frame: 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.

Time frame: 24 months

Secondary Outcomes

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;

Time frame: 24 months

Data from ClinicalTrials.gov

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