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A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS
A Phase 1b Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (MDS)
1 other identifier
interventional
32
1 country
3
Brief Summary
This is an open-label, phase 1b study to evaluate the safety, tolerability and preliminary efficacy of IBI188 in combination with Azacitidine in newly diagnosed higher risk MDS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2020
3 active sites
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
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 13, 2020
CompletedStudy Start
First participant enrolled
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2022
CompletedDecember 21, 2020
December 1, 2020
1.2 years
August 5, 2020
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse Events
Adverse events according to national Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 or customized AE severity grading as defined in the protocol
28 days
Efficacy of IBI188 in combination with AZA
International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS
28 days
Study Arms (1)
IBI188 + azacitidine
EXPERIMENTALParticipants will receive IBI188 in combination with azacitidine
Interventions
Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle
Eligibility Criteria
You may qualify if:
- Newly diagnosed MDS subjects with higher risk.
- Age ≥ 18 years old.
- Eastern Cooperative Oncology Group score of 0-2.
- 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.
- MDS subjects with lower risk.
- Subjects who have received chemotherapy.
- History of chronic hemolytic anemia
- 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 (3)
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817, United States
New Jersey Center for Cancer Research
Brick, New Jersey, 08724, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yi Luo
Innovent Biologics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 13, 2020
Study Start
August 24, 2020
Primary Completion
October 31, 2021
Study Completion
April 4, 2022
Last Updated
December 21, 2020
Record last verified: 2020-12