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)
1 other identifier
interventional
174
2 countries
10
Brief Summary
A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2017
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedStudy Start
First participant enrolled
February 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2025
CompletedAugust 1, 2025
July 1, 2025
5 years
December 15, 2016
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose-limiting toxicities (Number of participants with a DLT)
Number of participants with a DLT
Up to 28 days
Study Arms (6)
Evorpacept (ALX148)
EXPERIMENTALThe Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
Evorpacept (ALX148) + Pembrolizumab
EXPERIMENTALThe Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
Evorpacept (ALX148) + Trastuzumab
EXPERIMENTALThe Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
Evorpacept (ALX148) + Rituximab
EXPERIMENTALThe 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
EXPERIMENTALThe 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
EXPERIMENTALThe Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
Interventions
Evorpacept (ALX148)
Keytruda
Herceptin
Standard of care chemotherapy
Standard of care chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of Colorado Denver
Denver, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06520, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
START-Midwest
Grand Rapids, Michigan, 49503, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, 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
Related Publications (2)
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.
PMID: 40207726DERIVEDLakhani 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: 34793719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2016
First Posted
January 6, 2017
Study Start
February 3, 2017
Primary Completion
February 1, 2022
Study Completion
July 8, 2025
Last Updated
August 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share