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

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Suspended
• CT.gov ID: NCT04511975
• Collaborator: (none)
• Enrollment: 32
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 19.3
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
MDS	Drug: IBI188; Drug: Azacitidine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Aug 24, 2020
• Anticipated Primary Completion Date: Oct 31, 2021
• Anticipated Study Completion Date: Apr 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI188 + azacitidine Participants will receive IBI188 in combination with azacitidine	Drug: IBI188; IBI188: 100 mg/mL, intravenous infusion once a week; Drug: Azacitidine; Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle; Other Names: VIDAZA

Outcome Measures

Primary Outcome Measures

1. Adverse Events [28 days]

   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

2. Efficacy of IBI188 in combination with AZA [28 days]

   International Working Group (IWG) 2006 criteria will be used to evaluate efficacy of IBI188 in combination with AZA for response criteria for MDS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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-SIRPα agents.

6. Subjects participating in another interventional clinical study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American Oncology Partners of Maryland, PA	Bethesda	Maryland	United States	20817
2	New Jersey Center for Cancer Research	Brick	New Jersey	United States	08724
3	Gabrail Cancer Center	Canton	Ohio	United States	44718

Sponsors and Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.

Investigators

• Study Director: Yi Luo, Innovent Biologics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04511975
• Other Study ID Numbers: CIBI188A103
• First Posted: Aug 13, 2020
• Last Update Posted: Dec 21, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Innovent Biologics (Suzhou) Co. Ltd.: MDS
• Additional relevant MeSH terms: Azacitidine

Study Results

No Results Posted as of Dec 21, 2020