Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Evorpacept (ALX148), ALX148
evorpacept · 7 trials · 13 indications
Percentage of patients with objective response per RECIST 1.1
Overall Survival
The proportion of patients having either a complete response (CR) or partial response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
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.
To identify the RP2D of ALX148 in combination with enfortumab vedotin
Number of participants with a DLT
| 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. |
| ALX148 + Doxorubicin (PLD) + Pembrolizumab | EXPERIMENTAL | Given on Day 1 of each 21 day cycle, in the following order of administration: 200 mg IV pembrolizumab\* (maximum of 2 years (approximately 35 cycles) 45 mg/kg IV ALX148 30 mg/m\^2 IV doxorubicin (Pegylated Liposomal Doxorubicin (PLD)\* \*standard of care |
| 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 |
| 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 Q2W |
| Trastuzumab | DRUG | IV Q2W |
| Ramucirumab | DRUG | IV Q2W |
| Paclitaxel | DRUG | IV Days 1, 8, and 15 of a 28-day cycle |
| Pembrolizumab | DRUG | A type of immunotherapy that stimulates the body's immune system to fight cancer cells by targeting and blocking PD-1 proteins on the surface of certain immune T-cells, thus triggering the T-cells to find and kill cancer cells. |
| ALX148 | DRUG | A fusion protein comprised of a high affinity CD47 blocker linked to an inactive immunoglobulin Fc region, enhancing innate and adaptive immune responses against cancer. |
| Doxorubicin | DRUG | An anthracycline that slows/stops the growth of cancer cells by blocking an enzyme called topo isomerase 2, used as second line non-platinum chemotherapy in patients with platinum-resistant ovarian cancer. |
| Capecitabine | DRUG | Oral administration |
| Eribulin | DRUG | IV infusion |
| Gemcitabine | DRUG | IV infusion |
| Vinorelbine | DRUG | IV infusion |
| evorpacept | 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: * 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. * ...
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Evorpacept is an investigational biologic cancer therapy developed by ALX Oncology Holdings Inc. It is being studied in several tumor types, including metastatic breast cancer, gastric cancer, head and neck cancer, and bladder cancer. It is designed to be given in combination with other anticancer agents such as trastuzumab, pembrolizumab, chemotherapy, and enfortumab vedotin.
Evorpacept targets CD47 and acts as an inhibitor of that target. CD47 is a cell-surface protein often described as a don't-eat-me signal that cancer cells use to avoid immune clearance. By binding CD47, evorpacept is designed to block that signal and support immune-mediated attack on tumor cells.
Evorpacept is being developed by ALX Oncology Holdings Inc., which trades under the ticker ALXO. The company is running the ASPEN series of studies of evorpacept across multiple solid tumor indications, often in combination with established anticancer therapies.
Evorpacept is investigational and remains in clinical development. Its trials span Phase 1 through Phase 2/Phase 3, including a Phase 1 study in urothelial carcinoma, Phase 2 studies in head and neck cancer and metastatic HER2-positive breast cancer, and a Phase 2/Phase 3 study in advanced HER2-positive gastric cancer.
Evorpacept trials include NCT07007559 (ASPEN-09-03) in metastatic HER2-positive breast cancer, which is recruiting; NCT05524545 (ASPEN-07) with enfortumab vedotin in urothelial carcinoma, completed; NCT05002127 (ASPEN-06) in advanced HER2-positive gastric cancer, completed; and NCT04675333 (ASPEN-04) with pembrolizumab and chemotherapy in head and neck squamous cell carcinoma, active but not recruiting.
Yes, ALX148 is another name for evorpacept. The two names refer to the same investigational CD47-targeting biologic from ALX Oncology, and several of its clinical trials list it as evorpacept (ALX148) in their titles.