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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04511975
Other study ID # CIBI188A103
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date August 24, 2020
Est. completion date April 4, 2022

Study information

Verified date December 2020
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 32
Est. completion date April 4, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Main Inclusion Criteria: 1. Newly diagnosed MDS subjects with higher risk. 2. Age = 18 years old. 3. Eastern Cooperative Oncology Group score of 0-2. 4. Adequate organ function. 5. Subjects should take effective contraceptive measures. 6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures. Main Exclusion Criteria: 1. Subject who has transformed from MDS to AML. 2. MDS subjects with lower risk. 3. Subjects who have received chemotherapy. 4. History of chronic hemolytic anemia 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
IBI188: 100 mg/mL, intravenous infusion once a week
Azacitidine
Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle

Locations

Country Name City State
United States American Oncology Partners of Maryland, PA Bethesda Maryland
United States New Jersey Center for Cancer Research Brick New Jersey
United States Gabrail Cancer Center Canton Ohio

Sponsors (1)

Lead Sponsor Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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