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), also known as chronic myelogenous leukemia. It is currently in Phase 1 clinical trials for patients with chronic phase CML, including those with the BCR-ABL1 positive mutation and the T315I mutation.
ELVN-001 is a small molecule designed to target the BCR-ABL1 fusion protein, which drives chronic myeloid leukemia. It is being studied in patients with BCR-ABL1 positive CML, including those with the T315I mutation, which is resistant to many existing therapies.
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 for this investigational drug in patients with chronic myeloid leukemia.
ELVN-001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of therapies for serious conditions.
ELVN-001 is being studied in two Phase 1 trials. NCT05304377 is a Phase 1a/1b study enrolling 250 participants with chronic myeloid leukemia across multiple countries. NCT06787144 is a Phase 1 study enrolling 21 Japanese participants with CML, with or without the T315I mutation. Both trials are currently recruiting.
ELVN-001 is a distinct investigational drug and is not known to be the same as any other approved or marketed medication. It is being studied under its own name in clinical trials for chronic myeloid leukemia, and no alternative names have been reported.