Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as evorpacept
ALX148 · 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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ALX148 is an investigational small molecule being developed by ALX Oncology Holdings Inc. for the treatment of ovarian cancer. It is designed to target CD47, a checkpoint protein, and is currently in Phase 2 clinical development. ALX148 has not been approved by the FDA and remains under study in a single active clinical trial.
ALX148 is being studied for use in recurrent platinum-resistant ovarian cancer. The Phase 2 trial evaluates ALX148 in combination with liposomal doxorubicin and pembrolizumab in adult female patients with this condition. It is an investigational therapy and is not approved for any indication.
ALX148 targets CD47, a checkpoint protein. By binding to CD47, the drug is intended to interfere with a pathway that cancer cells use to evade immune detection. This mechanism is being explored in the Phase 2 ovarian cancer study, where ALX148 is combined with liposomal doxorubicin and pembrolizumab.
ALX148 is being developed by ALX Oncology Holdings Inc., which trades on the Nasdaq under the ticker ALXO. The company is the sponsor of the Phase 2 clinical trial evaluating ALX148 in recurrent platinum-resistant ovarian cancer in the United States.
ALX148 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting, and no completed trials of ALX148 are listed for this program.
ALX148 is being evaluated in one active clinical trial, NCT05467670, titled a study of anti-CD47 ALX148 in combination with liposomal doxorubicin and pembrolizumab in recurrent platinum-resistant ovarian cancer. The Phase 2 trial has an enrollment of 16 participants, is uncontrolled, and is being conducted in the United States.