A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
NCT ID: NCT03013218
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
174 participants
INTERVENTIONAL
2017-02-03
2025-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Evorpacept (ALX148)
The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
Evorpacept (ALX148)
Evorpacept (ALX148)
Evorpacept (ALX148) + 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)
Evorpacept (ALX148)
Pembrolizumab
Keytruda
Evorpacept (ALX148) + 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)
Evorpacept (ALX148)
Trastuzumab
Herceptin
Evorpacept (ALX148) + 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)
Evorpacept (ALX148)
Rituximab
Rituxan
Evorpacept (ALX148) + Pembrolizumab + 5FU + Platinum
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)
Evorpacept (ALX148)
Pembrolizumab
Keytruda
5-FU + Cisplatin
Standard of care chemotherapy
Evorpacept (ALX148) + Trastuzumab + 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.
Evorpacept (ALX148)
Evorpacept (ALX148)
Trastuzumab
Herceptin
Ramucirumab + Paclitaxel
Standard of care chemotherapy
Interventions
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Evorpacept (ALX148)
Evorpacept (ALX148)
Pembrolizumab
Keytruda
Trastuzumab
Herceptin
Rituximab
Rituxan
Ramucirumab + Paclitaxel
Standard of care chemotherapy
5-FU + Cisplatin
Standard of care chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Adequate Bone Marrow Function.
* Adequate Renal \& Liver Function.
* Adequate Performance Status
Exclusion Criteria
* Previous high-dose chemotherapy requiring allogenic stem cell rescue.
* Prior treatment with a CD47 or signal regulatory protein (SIRP) alpha targeting agent.
18 Years
ALL
No
Sponsors
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ALX Oncology Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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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.
Other Identifiers
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AT148001
Identifier Type: -
Identifier Source: org_study_id
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