Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk 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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2024-08-20

Brief Summary

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The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA) as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic syndrome

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Detailed Description

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Conditions

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Myelodysplastic Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IBI188+azacitidine

Group Type EXPERIMENTAL

IBI188+azacitidine

Intervention Type DRUG

Escalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W

Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W

Interventions

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IBI188+azacitidine

Escalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W

Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. MDS subjects with higher risk;
2. Age ≥ 18 years old;
3. Eastern Cooperative Oncology Group score of 0\~1;
4. Not suitable for or refuse to receive HSCT;
5. Newly diagnosed MDS subjects;
6. Adequate organ function;
7. Subjects should take effective contraceptive measures
8. 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. Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed MDS,MDS/MPN.
3. MDS subjects with lower risk.
4. Subjects who have received chemotherapy.
5. Prior exposure to any anti-CD47 or anti-SIRPα agents.
6. Subjects participating in another interventional clinical study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No