Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ELVN-001 · 2 trials · 5 indications
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
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 expansion is tolerable
Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in expansion is tolerable
Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in expansion 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 |
| Phase 1a Dose Escalation | EXPERIMENTAL | ELVN-001 administered in 3+3 dose escalation |
| Phase 1b Dose Expansion (non-T315I) | EXPERIMENTAL | ELVN-001 administered at one or more recommended dose(s) for expansion in CML without T315I mutations |
| Phase 1b expansion (T315I) | EXPERIMENTAL | ELVN-001 administered at the recommended dose for expansion for CML with T315I mutation |
| 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...
ELVN-001 is an investigational small molecule being developed for the treatment of chronic myeloid leukemia (CML), including chronic phase CML. It is currently in Phase 1 clinical trials for patients with CML, both with and without the T315I mutation.
ELVN-001 targets BCR-ABL, the fusion protein responsible for driving chronic myeloid leukemia. By inhibiting BCR-ABL, the drug aims to block the signaling that leads to uncontrolled growth of leukemic cells.
ELVN-001 is being developed by Enliven Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ELVN. The company is conducting Phase 1 clinical trials to evaluate the drug in patients with chronic myeloid leukemia.
ELVN-001 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug has received Fast Track designation from the FDA for its intended use in chronic myeloid leukemia.
ELVN-001 is being studied in two Phase 1 trials: NCT05304377, a Phase 1a/1b study in patients with chronic myeloid leukemia across multiple countries, and NCT06787144, a study specifically in Japanese participants with CML with or without the T315I mutation. Both trials are currently recruiting.