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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04485065
Other study ID # CIBI188C301
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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