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

• Status: Recruiting
• Trial end date: 2022-02-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

1. MDS subjects with higher risk;

2. Age ≥ 18 years old;

3. Eastern Cooperative Oncology Group score of 0~2;

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.