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

• Status: Suspended
• Trial end date: 2022-04-04
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

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.