Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Evorpacept (ALX148), ALX148
Evorpacept · 7 trials · 13 indications
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.
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 |
|---|---|---|
| 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 |
| 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 |
|---|---|---|
| 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. |
| 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 |
| 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: 1. Participants must have recurrent epithelial ovarian cancer. 2. Platinum-resistant disease: Patients who recur within \< 6 months of prior platinum-based therapy excluding those with primary platinum refractory disease (see exclusion criteria). 3. Following histology types are...
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Evorpacept is an investigational oncology drug being studied for metastatic cancer, breast cancer, gastric cancer, bladder cancer, and head and neck cancer. It is in clinical development for advanced solid tumors and lymphomas, and is being evaluated in combination with other therapies for specific cancer types.
Evorpacept targets CD47, a protein that cancer cells use to evade the immune system. It is a CD47 inhibitor, designed to block the "don't eat me" signal that CD47 sends to macrophages, potentially enabling the immune system to attack and destroy cancer cells.
Evorpacept is being developed by ALX Oncology Holdings Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ALXO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
Evorpacept is in Phase 1 and Phase 2 clinical trials. It is an investigational drug, not yet approved by the FDA. Ongoing trials include a Phase 2 study in head and neck cancer and a Phase 2 study in HER2+ gastric cancer, with earlier-stage trials completed.
Evorpacept is being studied in several clinical trials, including NCT03013218 (completed, advanced solid tumors and lymphoma), NCT04675333 (active, head and neck cancer), NCT05002127 (active, gastric cancer), and NCT05524545 (completed, bladder cancer). These trials are part of the ASPEN program.
Yes, Evorpacept is also known as ALX148. Both names refer to the same investigational drug being developed by ALX Oncology. Clinical trial registrations and scientific publications may use either name to describe the compound.