Description:
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.
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.
Suspended
Phase 1
Drug | Synonyms | Arms |
---|---|---|
IBI188 | IBI188 + azacitidine | |
Azacitidine | VIDAZA | IBI188 + azacitidine |
Name | Type | Description | Interventions |
---|---|---|---|
IBI188 + azacitidine | Experimental | Participants will receive IBI188 in combination with azacitidine |
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Adverse Events |
Time Frame: | 28 days |
Safety Issue: | |
Description: | 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 |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Suspended |
Lead Sponsor: | Innovent Biologics (Suzhou) Co. Ltd. |
December 21, 2020