Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02944955 | A Study of BLEX 404 Oral Liquid in Patients With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-Risk Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML) | PHASE2 | NOT YET_RECRUITING | 52 | — | — | Jan 1, 2027 | Dec 31, 2028 | Apr 13, 2026 | - | — |
RDL is defined by BLEX 404 Oral Liquid-related prohibited toxicity in subjects undergoing 2 cycles of azacitidine treatment. When one of the stopping criteria is met during the study treatment period, RDL will be set at the lower dose level.
Number of subjects experience infection events and inpatient hospitalization due to infections.
| Arm | Type | Description |
|---|---|---|
| BLEX 404 Oral Liquid | EXPERIMENTAL | Part I: Part I-1: Low Dose BLEX 404 Oral Liquid (3 mg/kg, BID) is administered in combination with 2 cycles of azacitidine. Part I-2: High Dose BLEX 404 Oral Liquid (4.5 mg/kg, BID) is administered in combination with 2 cycles of azacitidine. Part II: Recommended Dose Level (RDL) of BLEX 404 Oral Liquid will be determined by results from Part I. BLEX 404 Oral Liquid at RDL is administered in combination with 6 cycles of azacitidine. |
| Name | Type | Description |
|---|---|---|
| BLEX 404 Oral Liquid | DRUG | BLEX 404 Oral Liquid is orally administered twice daily in combination with azacitdine treatment cycles (2 cycles in Part I and 6 cycles in Part II). Azacitidine treatment: SC or IV injections at 75 mg/m2, QD for 7 days each cycle. 28 days/cycle, and repeat cycles every 4 weeks. |
Inclusion Criteria: * Age 20 or older, able to sign informed consent, understand and comply with protocol requirements and instructions. * Body weight between 30 to 120 kg * International Prognostic Scoring System (IPSS) intermediate-1 (int-1), intermediate-2 (int-2) or high-risk myelodysplastic sy...