Back to resultsEfficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI188
Azacitidine
Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML).
- Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys).
- Age ≥18 years old, gender not limited.
- ECOG score of 0-2.
- Adequate organ function.
Exclusion Criteria:
- Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).
- Prior exposure to any anti-CD47 or anti-SIRPα agents.
- Major surgery and vaccine treatment within 4 weeks.
- Uncontrolled concurrent diseases.
- Pregnant or breastfeeding female subjects.
Sites / Locations
- The First Affiliated Hospital of Soochow University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IBI188+azacitidine
IBI188+decitabine
Arm Description
1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)
R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
Outcomes
Primary Outcome Measures
Composite complete rate
Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery
Secondary Outcome Measures
Cytogenetic CR
Full Information
NCT ID
NCT04485052
First Posted
July 21, 2020
Last Updated
October 20, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04485052
Brief Title
Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia
Official Title
A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Pause for changes in development strategies
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 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, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
222 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBI188+azacitidine
Arm Type
Experimental
Arm Description
1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)
Arm Title
IBI188+decitabine
Arm Type
Experimental
Arm Description
R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
Intervention Type
Drug
Intervention Name(s)
IBI188
Intervention Description
anti-CD47 Monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Demethylation drugs
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
Demethylation drugs
Primary Outcome Measure Information:
Title
Composite complete rate
Description
Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Cytogenetic CR
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML).
Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys).
Age ≥18 years old, gender not limited.
ECOG score of 0-2.
Adequate organ function.
Exclusion Criteria:
Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase).
A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients.
Major surgery and vaccine treatment within 4 weeks.
Uncontrolled concurrent diseases.
Pregnant or breastfeeding female subjects.
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia
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