Clinical trial · Interventional
A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
NCT03013218CI-TRIAL-00092993completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| NonHodgkin Lymphoma | Non-Hodgkin Lymphoma | PROBABILISTIC | 0.70 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU + Cisplatin | Drug | — | UNRESOLVED |
| Evorpacept (ALX148) | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Ramucirumab + Paclitaxel | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Evorpacept (ALX148)
- description
- The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
- interventionNames
- Drug: Evorpacept (ALX148)
- type
- EXPERIMENTAL
- label
- Evorpacept (ALX148) + Pembrolizumab
- description
- The Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
- interventionNames
- Drug: Evorpacept (ALX148)
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Evorpacept (ALX148) + Trastuzumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDKim 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. PMID 40207726
- DERIVEDLakhani 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. PMID 34793719