Back to resultsSafety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
Primary Purpose
Myelodysplastic Syndromes
Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI188+azacitidine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring MDS
Eligibility Criteria
Inclusion Criteria:
- MDS subjects with higher risk;
- Age ≥ 18 years old;
- Eastern Cooperative Oncology Group score of 0~2;
- Not suitable for or refuse to receive HSCT;
- Newly diagnosed MDS subjects;
- Adequate organ function;
- Subjects should take effective contraceptive measures
- Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Exclusion Criteria:
- Subject who has transformed from MDS to AML.
- Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
- MDS subjects with lower risk.
- Subjects who have received chemotherapy.
- Prior exposure to any anti-CD47 or anti-SIRPα agents.
- Subjects participating in another interventional clinical study.
Sites / Locations
- Blood Diseases Hospital Chinese Academy Of Medical Science
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBI188+azacitidine
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability
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)
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
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;
Full Information
NCT ID
NCT04485065
First Posted
July 21, 2020
Last Updated
February 14, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04485065
Brief Title
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Suspended for changes in development strategy
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
MDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBI188+azacitidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IBI188+azacitidine
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)
Time Frame
24 months
Title
Complete response rate (CR) and duration of complete response (DoCR)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Complete response rate (CR) and duration of complete response (DoCR)
Description
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;
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MDS subjects with higher risk;
Age ≥ 18 years old;
Eastern Cooperative Oncology Group score of 0~1;
Not suitable for or refuse to receive HSCT;
Newly diagnosed MDS subjects;
Adequate organ function;
Subjects should take effective contraceptive measures
Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.
Exclusion Criteria:
Subject who has transformed from MDS to AML.
Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
MDS subjects with lower risk.
Subjects who have received chemotherapy.
Prior exposure to any anti-CD47 or anti-SIRPα agents.
Subjects participating in another interventional clinical study.
Facility Information:
Facility Name
Blood Diseases Hospital Chinese Academy Of Medical Science
City
Tianjin
Country
China
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
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