Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia

A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia

Status

Suspended

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04485052

Enrollment

222

Registered

2020-07-24

Start date

2020-09-25

Completion date

2024-12-31

Last updated

2023-10-23

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

Conditions

Acute Myeloid Leukemia

Brief summary

The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia

Interventions

DRUGIBI188

anti-CD47 Monoclonal antibody

DRUGAzacitidine

Demethylation drugs

DRUGDecitabine

Demethylation drugs

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except M3-type and BCR-ABL positive AML). 2. Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive chemotherapy( ≥60 ys). 3. Age ≥18 years old, gender not limited. 4. ECOG score of 0-2. 5. Adequate organ function.

Exclusion criteria

1. Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia, CMML(accelerated phase and blast phase). 2. A history of myeloproliferative diseases (including myelofibrosis, primary thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid white blood with BCR-ABL1 translocation Patients. 3. Major surgery and vaccine treatment within 4 weeks. 4. Uncontrolled concurrent diseases. 5. Pregnant or breastfeeding female subjects.

Design outcomes

Primary

Measure	Time frame	Description
Composite complete rate	24 weeks	Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery

Secondary

Measure	Time frame
Cytogenetic CR	24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026