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

A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome

Status

Suspended

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04485065

Enrollment

120

Registered

2020-07-24

Start date

2020-09-30

Completion date

2024-08-20

Last updated

2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

MDS

Brief summary

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

Interventions

DRUGIBI188+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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	24 months	To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)
Complete response rate (CR) and duration of complete response (DoCR)	24 months	Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the central laboratory.

Secondary

Measure	Time frame	Description
Complete response rate (CR) and duration of complete response (DoCR)	24 months	Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the investigators;

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026