A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
| Registry | NCT03013218 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 174 (Actual) |
| Sponsor | ALX Oncology Inc. (Industry) |
| Conditions | Metastatic Cancer, Solid Tumor, Advanced Cancer, NonHodgkin Lymphoma |
| Interventions | Evorpacept (ALX148), Pembrolizumab, Trastuzumab, Rituximab, Ramucirumab + Paclitaxel, 5-FU + Cisplatin (Drug) |
| Dates | start 2017-02-03, primary completion 2022-02-01, completion 2025-07-08, first posted 2017-01-06, last updated 2025-08-01 |
| Locations | 10 sites in United States, South Korea |
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A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma
This phase 1 clinical study (AT148001) is an open-label, multi-center, multiple-dose, dose-escalation, safety, PK, and PD study of evorpacept (ALX148). The phase 1 protocol will have 2 parts: a single agent dose escalation phase (Part 1) and a combination therapy phase (Part 2). Part 2 will include an initial dose escalation portion followed by a dose expansion portion. Approximately 184 adult patients are expected to be enrolled in the study.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Evorpacept (ALX148) | Experimental | Drug: Evorpacept (ALX148) | The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks. |
| Evorpacept (ALX148) + Pembrolizumab | Experimental | Drug: Evorpacept (ALX148); Drug: Pembrolizumab | The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions. |
| Evorpacept (ALX148) + Trastuzumab | Experimental | Drug: Evorpacept (ALX148); Drug: Trastuzumab | 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 | Drug: Evorpacept (ALX148); Drug: Rituximab | 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 | Drug: Evorpacept (ALX148); Drug: Pembrolizumab; Drug: 5-FU + Cisplatin | 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 | Drug: Evorpacept (ALX148); Drug: Trastuzumab; Drug: Ramucirumab + Paclitaxel | The Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy; or relapsed or refractory Non-Hodgkin lymphoma for whom no standard therapy is available.. * Adequate Bone Marrow Function. * Adequate Renal \& Liver Function. * Adequate Performance Status Exclusion Criteria: * Patients with known symptomatic CNS metastases or lepotomeningeal disease requiring steroids. * Previous high-dose chemotherapy requiring allogenic stem cell rescue. * Prior treatment with a CD47 or signal regulatory protein (SIRP) alpha targeting agent.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Colorado Denver | Denver, Colorado | United States | |
| Yale University | New Haven, Connecticut | United States | |
| Massachusetts General Hospital | Boston, Massachusetts | United States | |
| Dana Farber Cancer Institute | Boston, Massachusetts | United States | |
| START-Midwest | Grand Rapids, Michigan | United States | |
| Seattle Cancer Care Alliance | Seattle, Washington | United States | |
| Seoul National University Bundang Hospital | Seongnam | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| Seoul National University Hospital | Seoul | South Korea | |
| Severance Hospital, Yonsei University | Seoul | South Korea |