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

Innovent Biologics

Status and phase: Suspended; Phase 1

Conditions: MDS

Treatments: Drug: Azacitidine; Drug: IBI188

Study type: Interventional

Funder types: Industry

Identifiers

NCT04511975

CIBI188A103

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 1 patient group

IBI188 + azacitidine

Experimental group

Description:

Participants will receive IBI188 in combination with azacitidine

Treatment:

Drug: Azacitidine

Drug: IBI188