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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06419634 | Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome | PHASE1 | RECRUITING | 105 | — | — | May 29, 2024 | Sep 16, 2030 | Apr 8, 2026 | 16 | United States, Canada +2 |
The combination therapy included BMS-986497 and Azacitidine
The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation BMS-986497 (Monotherapy) | EXPERIMENTAL | - |
| Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy) | EXPERIMENTAL | - |
| Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986497 | DRUG | Specified dose on specified days |
| Azacitidine | DRUG | Specified dose on specified days |
| Venetoclax | DRUG | Specified dose on specified days |
Inclusion Criteria: * Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). * Detectable levels of cluster of differentiation 33 (CD33) expression. * Failed alternative therapies with established benefit. * Eastern Cooperative On...