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

Myelodysplastic Syndromes Clinical Trial

Official title:

A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04485065
• Other study ID #: CIBI188C301
• Status: Suspended
• Phase: Phase 1
• Start date: September 30, 2020
• Est. completion date: August 20, 2024

Study information

• Verified date: February 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: August 20, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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-SIRPa agents.

6. Subjects participating in another interventional clinical study.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• IBI188+azacitidine
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

Locations

Country	Name	City	State
China	Blood Diseases Hospital Chinese Academy Of Medical Science	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)	24 months
Primary	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.	24 months
Secondary	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;	24 months