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

Phase 1

Suspended

• Conditions: MDS
• Interventions: Drug: IBI188; Drug: Azacitidine

• Registration Number: NCT04511975
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Study Start: 2020-08-24
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21
• Primary Completion: 2021-10-31
• Study Completion: 2022-04-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IBI188 + azacitidine	IBI188	Participants will receive IBI188 in combination with azacitidine
IBI188 + azacitidine	Azacitidine	Participants will receive IBI188 in combination with azacitidine

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (3)

Gabrail Cancer Center; 🇺🇸 Canton, Ohio, United States

American Oncology Partners of Maryland, PA; 🇺🇸 Bethesda, Maryland, United States

New Jersey Center for Cancer Research; 🇺🇸 Brick, New Jersey, United States