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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-24

Study Completion Date

2022-04-04

Brief Summary

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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.

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Detailed Description

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Conditions

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MDS

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IBI188 + azacitidine

Participants will receive IBI188 in combination with azacitidine

Group Type EXPERIMENTAL

IBI188

Intervention Type DRUG

IBI188: 100 mg/mL, intravenous infusion once a week

Azacitidine

Intervention Type DRUG

Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle

Interventions

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IBI188

IBI188: 100 mg/mL, intravenous infusion once a week

Intervention Type DRUG

Azacitidine

Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle

Intervention Type DRUG

Other Intervention Names

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VIDAZA

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No