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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06328738 | ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 275 | — | — | May 30, 2024 | Jul 1, 2028 | Nov 19, 2025 | 31 | United States, Belgium +5 |
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. |
| 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 |
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 (...