drugset / Trial / NCT03013218
A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma
Timeline
- Start
- 2017-02-03
- Primary completion
- 2022-02-01
- Completion
- 2025-07-08
Publications
- Kim TM, Lakhani NJ, Soumerai J, Kamdar M, Gainor JF, Messersmith W, Fanning P, Guan S, Jin F, Forgie A, Wan HI, Pons J, Randolph SS, Kim WS. Evorpacept plus rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma: results from the phase I ASPEN-01 study. Haematologica. 2025 Sep 1;110(9):2102-2112. doi: 10.3324/haematol.2024.286208. Epub 2025 Apr 10.
- Lakhani NJ, Chow LQM, Gainor JF, LoRusso P, Lee KW, Chung HC, Lee J, Bang YJ, Hodi FS, Kim WS, Santana-Davila R, Fanning P, Squifflet P, Jin F, Kuo TC, Wan HI, Pons J, Randolph SS, Messersmith WA. Evorpacept alone and in combination with pembrolizumab or trastuzumab in patients with advanced solid tumours (ASPEN-01): a first-in-human, open-label, multicentre, phase 1 dose-escalation and dose-expansion study. Lancet Oncol. 2021 Dec;22(12):1740-1751. doi: 10.1016/S1470-2045(21)00584-2. Epub 2021 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evorpacept | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | Evorpacept | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | Evorpacept | Protein / enzyme biologic | 3 mg/kg | Intravenous |
| Subject | Evorpacept | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | Evorpacept | Protein / enzyme biologic | 15 mg/kg | Intravenous |
| Subject | Evorpacept | Protein / enzyme biologic | 30 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Ramucirumab | Monoclonal antibody | — | — |
| Background | fluorouracil | Small molecule | — | — |