A Study Evaluating the Safety and Efficacy of IBI188 in Combination With AZA in Subjects With Newly Diagnosed MDS

MDS Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04511975
• Other study ID #: CIBI188A103
• Status: Suspended
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• MDS

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