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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06787144 | ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants | PHASE1 | RECRUITING | 21 | — | — | Jan 23, 2025 | Jan 1, 2028 | Jul 1, 2025 | 4 | Japan |
DLTs will be used to support that the recommended doses for expansion are \</= MTD
Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable
Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Adverse events will be used to support that the dose(s) evaluated in exploration is tolerable
Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in exploration is tolerable
Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in exploration is tolerable
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation | EXPERIMENTAL | ELVN-001 administered in 3+3 dose escalation |
| Part 2 Dose Exploration | EXPERIMENTAL | ELVN-001 administered to approximately 6 participants per dose level who may be enrolled at or below the dose levels that have been deemed safe and tolerable in Part 1 |
| Name | Type | Description |
|---|---|---|
| ELVN-001 | DRUG | Orally once or twice daily |
Inclusion Criteria: * BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs. * ECOG performance status of 0 to 2. * The patient was born in Japan and both parents and grandparents are Japanese. * Adequate hematologic, hepatic and r...