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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05002127 | A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) | PHASE2 | ACTIVE NOT_RECRUITING | 127 | — | — | Jan 15, 2022 | Jun 1, 2026 | Aug 7, 2025 | 83 | United States, Australia +10 |
Percentage of patients with objective response per RECIST 1.1
Overall Survival
| Arm | Type | Description |
|---|---|---|
| Phase 2 - Arm A | EXPERIMENTAL | Evorpacept (ALX148) 30 mg/kg every two weeks (Q2W) intravenous (IV), trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle. |
| Phase 2 - Arm B | ACTIVE_COMPARATOR | Trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle. |
| Phase 3 - Arm A | EXPERIMENTAL | Evorpacept (ALX148) 30 mg/kg Q2W IV, trastuzumab (initial dose of 6 mg/kg followed by 4 mg/kg) Q2W IV, ramucirumab 8 mg/kg Q2W IV, and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle. |
| Phase 3 - Arm B | ACTIVE_COMPARATOR | Ramucirumab 8 mg/kg Q2W IV and paclitaxel 80 mg/m2 IV Days 1, 8, and 15 of a 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Evorpacept (ALX148) | DRUG | IV Q2W |
| Trastuzumab | DRUG | IV Q2W |
| Ramucirumab | DRUG | IV Q2W |
| Paclitaxel | DRUG | IV Days 1, 8, and 15 of a 28-day cycle |
Inclusion Criteria: * HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after a prior HER2-directed agent and fluoropyrimidine- or platinum-containing chemotherapy (2nd-line or 3rd-line) * Adequate Bone Marrow Function. * ...