Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
evorpacept · 6 trials · 12 indications
Evaluate the ORR of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic HER2-positive breast cancer who express CD47 (CD47+). ORR is defined as a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST v1.1 based on BICR assessment.
Percentage of patients with objective response per RECIST 1.1
Overall Survival
To identify the RP2D of ALX148 in combination with enfortumab vedotin
Number of participants with a DLT
| Arm | Type | Description |
|---|---|---|
| Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer | EXPERIMENTAL | * Evorpacept (IV) - once every 3 weeks (Q3W) * Trastuzumab (IV) - once every 3 weeks (Q3W) * Chemotherapy (physician selects one of the following): * Capecitabine (Oral) twice a day for 14 days every 3 weeks * Eribulin (IV) twice every 3 weeks * Gemcitabine (IV) twice every 3 weeks * Paclitaxel (IV) once every 3 weeks (Q3W) or once weekly (QW) * Vinolrebine (IV) twice every 3 weeks |
| 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. |
| evorpacept (ALX148) + pembrolizumab + Chemotherapy | EXPERIMENTAL | evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks. |
| pembrolizumab + Chemotherapy | ACTIVE_COMPARATOR | pembrolizumab 200 mg IV and chemotherapy given every 3 weeks. |
| evorpacept (ALX148) + pembrolizumab | EXPERIMENTAL | evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks. |
| pembrolizumab | ACTIVE_COMPARATOR | pembrolizumab 200 mg IV given every 3 weeks. |
| Evorpacept (ALX148) + Enfortumab Vedotin | EXPERIMENTAL | Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks. Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle. |
| Evorpacept (ALX148) | EXPERIMENTAL | The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks. |
| Evorpacept (ALX148) + Trastuzumab | EXPERIMENTAL | The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions. |
| Evorpacept (ALX148) + Rituximab | EXPERIMENTAL | The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions. |
| Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum | EXPERIMENTAL | The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions. |
| Evorpacept (ALX148) + Trastuzumab + Ramucirumab + Paclitaxel | EXPERIMENTAL | The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions. |
| Name | Type | Description |
|---|---|---|
| Evorpacept (ALX148) | DRUG | IV infusion |
| Trastuzumab | DRUG | IV infusion |
| Paclitaxel | DRUG | IV infusion |
| Capecitabine | DRUG | Oral administration |
| Eribulin | DRUG | IV infusion |
| Gemcitabine | DRUG | IV infusion |
| Vinorelbine | DRUG | IV infusion |
| Ramucirumab | DRUG | IV Q2W |
| evorpacept | DRUG | IV Q3W |
| pembrolizumab | DRUG | IV Q3W |
| Cisplatin/Carboplatin; 5FU | DRUG | IV Q3W |
| Enfortumab Vedotin | DRUG | Nectin-4 directed antibody and microtubule inhibitor conjugate |
| Rituximab | DRUG | Rituxan |
| Ramucirumab + Paclitaxel | DRUG | Standard of care chemotherapy |
| 5-FU + Cisplatin | DRUG | Standard of care chemotherapy |
Inclusion Criteria: * Histologically confirmed invasive HER2+ breast cancer. * Received at least one prior line of therapy including T-DXd (ENHERTU) for locally advanced/metastatic HER2+ breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will b...
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