Clinical trial · Interventional
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
NCT04485052CI-TRIAL-00070714suspendedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pause for changes in development strategies
Summary
Brief summary (as posted)
The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating Agents in acute myeloid leukemia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| IBI188 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IBI188+azacitidine
- description
- 1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)
- interventionNames
- Drug: IBI188
- Drug: Azacitidine
- type
- EXPERIMENTAL
- label
- IBI188+decitabine
- description
- R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
- interventionNames
- Drug: IBI188
- Drug: Decitabine
Primary outcomes (1)
- measure
- Composite complete rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.