Approval Probability
TA Base Rate
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 developed by Enliven Therapeutics, Inc. (ticker ELVN) for HER2-driven cancers. It is being studied in HER2 mutant non-small cell lung cancer and HER2-positive breast cancer, along with other HER2-positive or HER2-amplified solid tumors. It is currently in Phase 1 clinical development.
ELVN-002 targets HER2, a receptor tyrosine kinase that drives tumor growth when mutated, amplified, or overexpressed. By binding HER2, the small molecule is designed to inhibit signaling from this target. Enliven Therapeutics is evaluating ELVN-002 in cancers selected for HER2 alterations, including HER2 mutant non-small cell lung cancer and HER2-positive breast cancer.
ELVN-002 is being evaluated as a treatment for HER2 mutant non-small cell lung cancer. It is also under study in HER2-positive metastatic breast cancer, HER2-positive breast cancer, HER2-positive gastric cancer, HER2 amplification, and colorectal cancer. The drug remains investigational and has not been approved for any indication.
ELVN-002 is being developed by Enliven Therapeutics, Inc., which trades on the Nasdaq under the ticker ELVN. The company is the sponsor of the Phase 1 clinical program evaluating the small molecule in HER2-altered solid tumors, including HER2 mutant non-small cell lung cancer and HER2-positive breast cancer.
ELVN-002 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. Enliven Therapeutics is running two active Phase 1 studies, one in HER2 mutant non-small cell lung cancer and one in HER2-positive solid tumors, colorectal cancer, and breast cancer.
ELVN-002 is being studied in two active Phase 1 trials. NCT05650879 evaluates ELVN-002 in HER2 mutant non-small cell lung cancer and HER2-positive metastatic breast cancer. NCT06328738 evaluates ELVN-002 with trastuzumab, with or without chemotherapy, in HER2-positive solid tumors, colorectal cancer, and breast cancer. Both trials are active but not recruiting.