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

Phase 1

Suspended

• Conditions: Myelodysplastic Syndromes
• Interventions: Drug: IBI188+azacitidine

• Registration Number: NCT04485065
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-24
• Study Start: 2020-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-12-30
• Study Completion: 2024-08-20

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI188+azacitidine	IBI188+azacitidine	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	24 months	To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)
Complete response rate (CR) and duration of complete response (DoCR)	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Complete response rate (CR) and duration of complete response (DoCR)	24 months	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;

Trial Locations

Locations (1)

Blood Diseases Hospital Chinese Academy Of Medical Science; 🇨🇳 Tianjin, China