Approval Probability
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Adjusted LOA
ML Risk
ELVN-002 · 2 trials · 8 indications
DLTs will be used to support that the recommended doses for expansion are \</= maximum tolerated dose (MTD)
AEs 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 electrocardiogram abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
| Arm | Type | Description |
|---|---|---|
| Part 1: ELVN-002 + trastuzumab dose escalation | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. |
| Part 2A: ELVN-002 + trastuzumab + CAPEOX dose escalation in colorectal cancer | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Capecitabine will be administered orally twice daily at 1000 mg/m2 on days 1 - 14 of a 21-day cycle. Oxaliplatin will be administered intravenously at 130 mg/m2 on day 1 of a 21-day cycle. |
| Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancer | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered intravenously at 6 mg/kg IV cycle 1, day 2 followed by 4 mg/kg IV cycle 1, day 15, and then one dose at 4mg/kg IV every 14 days. Fluorouracil (5-FU) will be administered intravenously as a 400 mg/m2 IV bolus on days 1 and 15 followed by 2400 mg/m2 over 46-48 hours of continuous infusion on days 1-3 and days 15-17 of a 28-day cycle. Leucovorin will be administered intravenously at 400 mg/m2 concurrently with oxaliplatin on days 1 and 15 of a 28-day cycle. Oxaliplatin will be administered intravenously at 85 mg/m2 IV on day 1 and 15 of a 28-day cycle. |
| Part 2C: ELVN-002 + trastuzumab + capecitabine dose escalation in breast cancer | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Capecitabine will be administered orally twice daily at 1000 mg/m2 on days 1 - 14 of a 21-day cycle. |
| Part 2D: ELVN-002 + trastuzumab + paclitaxel dose escalation in solid tumors | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Paclitaxel will be administered intravenously at 80 mg/m2 on days 1, 8, and 15 of a 21-day cycle. |
| Part 2E: ELVN-002 + trastuzumab + eribulin dose escalation in breast cancer | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Eribulin will be administered intravenously at 1.4 mg/m2 on days 1 and 8 of a 21-day cycle. |
| Part 3A: ELVN-002 + trastuzumab dose expansion in colorectal cancer | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+ |
| Part 3B: ELVN-002 + trastuzumab dose expansion in breast cancer | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. |
| Part 3C: ELVN-002 + trastuzumab dose expansion in other solid tumor type 1 | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. |
| Part 3D: ELVN-002 + trastuzumab dose expansion in other solid tumor type 2 | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. |
| Part 3E: ELVN-002 + trastuzumab dose expansion in other solid tumor type 3 | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. |
| Part 4A: ELVN-002 + trastuzumab + CAPEOX dose expansion in colorectal cancer | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Capecitabine will be administered orally twice daily at 1000 mg/m2 on Days 1 - 14 of a 21-day cycle. Oxaliplatin: will be administered intravenously at 130 mg/m2 on Day 1 of a 21-day cycle. |
| Part 4B: ELVN-002 + trastuzumab + mFOLFOX6 dose expansion in colorectal cancer | EXPERIMENTAL | ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered intravenously at 6 mg/kg IV cycle 1, day 2 followed by 4 mg/kg IV cycle 1, day 15, and then one dose at 4mg/kg IV every 14 days. Fluorouracil (5-FU) will be administered intravenously as a 400 mg/m2 IV bolus on days 1 and 15 followed by 2400 mg/m2 over 46-48 hours of continuous infusion on days 1-3 and days 15-17 of a 28-day cycle. Leucovorin will be administered intravenously at 400 mg/m2 concurrently with oxaliplatin on days 1 and 15 of a 28-day cycle. Oxaliplatin will be administered intravenously at 85 mg/m2 IV on days 1 and 15 of a 28-day cycle. |
| Phase 1a Monotherapy Dose Escalation | EXPERIMENTAL | ELVN-002 will be administered either once or twice daily. Each cohort of patients will receive a higher dose. ELVN-002 is an oral capsule. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason. |
| Phase 1a Monotherapy Dose Exploration | EXPERIMENTAL | ELVN-002 will be administered either once or twice daily. A maximum of 80 patients will enroll in this arm. A maximum of 10 patients may be enrolled at a single dose or tumor type. ELVN-002 is an oral capsule. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason. |
| Phase 1b Monotherapy Dose Expansion | EXPERIMENTAL | ELVN-002 will be administered either once or twice daily. A maximum of 40 patients will enroll in this arm. Patients will be randomized 1:1 to one of two dose levels. ELVN-002 is an oral capsule. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason. |
| Phase 1a Combination Dose Escalation with T-DXd | EXPERIMENTAL | ELVN-002 will be administered either once or twice daily starting on Day 1. ELVN-002 is an oral capsule. Each cohort will receive a higher dose of ELVN-002. All patients in all cohorts will initiate with 5.4mg/kg of intravenous T-DXd once every 3 weeks starting on day 22 of the study. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason. |
| Phase 1a Combination Dose Escalation with T-DM1 | EXPERIMENTAL | ELVN-002 will be administered either once or twice daily starting on Day 1. ELVN-002 is an oral capsule. Each cohort will receive a higher dose of ELVN-002. All patients in all cohorts will initiate with 3.6 mg/kg of intravenous T-DM1 once every 3 weeks starting on day 22 of the study. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason. |
| Name | Type | Description |
|---|---|---|
| ELVN-002 | DRUG | capsule |
| Trastuzumab | DRUG | intravenous |
| 5-Fluorouracil | DRUG | intravenous |
| Oxaliplatin | DRUG | intravenous |
| Capecitabine | DRUG | capsule |
| Eribulin | DRUG | intravenous |
| paclitaxel | DRUG | intravenous |
| Leucovorin | DRUG | intravenous |
| Fam-Trastuzumab Deruxtecan-Nxki | DRUG | intravenous |
| Trastuzumab emtansine | DRUG | intravenous |
Inclusion Criteria: * Pathologically or histologically documented solid tumor. * Locally advanced or relapsed/refractory disease or unresectable metastatic disease. * HER2-positive disease based on the following local testing: * Colorectal cancer: IHC3+, IHC2+/ISH+, NGS amplification by tissue (...
ELVN-002 is an investigational small molecule being studied for HER2 mutant non-small cell lung cancer and HER2-positive breast cancer. It is also being evaluated in HER2-positive gastric cancer, HER2 positive solid tumors, HER2 amplification, and colorectal cancer. The drug is in Phase 1 clinical development and is not yet approved.
ELVN-002 targets HER2, a protein involved in cell growth that is altered in certain cancers. By targeting HER2, the drug is designed to interfere with signaling pathways that drive tumor growth in cancers with HER2 mutations or amplification. It is being studied as a monotherapy and in combination with other treatments.
ELVN-002 is being developed by Enliven Therapeutics, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol ELVN. Enliven is conducting clinical trials to evaluate the safety and efficacy of ELVN-002 in patients with HER2-altered cancers.
ELVN-002 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trials are assessing the drug's safety, tolerability, and preliminary efficacy in patients with HER2-altered cancers, including non-small cell lung cancer and breast cancer.
ELVN-002 is being studied in two Phase 1 clinical trials. NCT06328738 evaluates ELVN-002 with trastuzumab plus or minus chemotherapy in HER2-positive solid tumors, colorectal cancer, and breast cancer. NCT05650879 evaluates ELVN-002 in HER2 mutant non-small cell lung cancer and HER2-positive metastatic breast cancer. Both trials are active but not recruiting.
ELVN-002 is the primary name for this investigational drug. No alternative names have been reported in clinical trial registries. It is a distinct small molecule being developed by Enliven Therapeutics for HER2-altered cancers, and it is not known to be identical to any other approved or investigational therapy.