Study Stopped
Suspended for changes in development strategy
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedStudy Start
First participant enrolled
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2024
CompletedFebruary 16, 2023
February 1, 2023
3.2 years
July 21, 2020
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Complete response rate (CR) and duration of complete response (DoCR)
24 months
Study Arms (1)
IBI188+azacitidine
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Blood Diseases Hospital Chinese Academy Of Medical Science
Tianjin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2020
First Posted
July 24, 2020
Study Start
September 30, 2020
Primary Completion
December 30, 2023
Study Completion
August 20, 2024
Last Updated
February 16, 2023
Record last verified: 2023-02