ClinicalTrials.gg
CompletedNCT03013218Updated Aug 1, 2025

A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

A Phase 1 interventional study of Evorpacept (ALX148) and Pembrolizumab in Metastatic Cancer, Solid Tumor and Advanced Cancer, sponsored by ALX Oncology Inc.. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by ALX Oncology Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2022, 4 years 9 months ago, and no results have been posted to the registry.

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Phase
Phase 1
Study type
Interventional
Enrollment
174
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 2,053 studies in Neoplasm Metastasis with a site in United States — 345 open to participants now, 541 under way, 58 of them phase 3. Neoplasm Metastasis · United States.

Enrollment
339th of 1,862
174 · median 43
Started
2017
with 79 others
Phase 1
709 of 2,053
128 open now
Registered
1,143rd of 2,053
by date

Among the 2,053 studies in Neoplasm Metastasis with a site in United States, this one is the 339th largest by enrollment of the 1,862 interventional ones that give a count, is one of 80 that started in 2017, is one of 709 in phase 1, and was the 1,143rd registered.

Neoplasm Metastasis

4,045 studies on the registry are indexed under Neoplasm Metastasis; 888 are open to participants now.

Browse Neoplasm Metastasis studies →

Open to participants now

345 of the 2,053 studies in Neoplasm Metastasis with a site in United States are open now. Recruiting first, the newest first:

340 more — sign in →

All 345 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 689 Neoplasm Metastasis studies recruiting now, 536 (78%) set no upper age limit and 97 (14%) stop at 75 or younger; 48 take children under 18; 18 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

A phase 1, dose escalation study of evorpacept (ALX148) in patients with advanced solid tumors and lymphoma

Read the detailed description

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.

03

Conditions studied

  • Metastatic Cancer
  • Solid Tumor
  • Advanced Cancer
  • NonHodgkin Lymphoma

Keywords

  • Neoplasms
  • CD47
  • SIRPα
  • ALX148
  • Evorpacept
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histological or cytological diagnosis of advanced/ solid tumor ; or Non-Hodgkin lymphoma for whom no standard therapy is available..
  • Adequate Bone Marrow Function.
  • Adequate Renal \& Liver Function.
  • Adequate Performance Status

Exclusion criteria

Exclusion Criteria:

  • Patients with known symptomatic or lepotomeningeal disease requiring .
  • Previous high-dose chemotherapy requiring allogenic stem cell rescue.
  • Prior treatment with a 7 or signal regulatory protein (SIRP) alpha targeting agent.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
174 participants (actual)

Study arms

  • Experimental
    Evorpacept (ALX148)

    The Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.

    Drug: Evorpacept (ALX148)

  • Experimental
    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.

    Drug: Evorpacept (ALX148) · Drug: Pembrolizumab

  • Experimental
    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.

    Drug: Evorpacept (ALX148) · Drug: Trastuzumab

  • Experimental
    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.

    Drug: Evorpacept (ALX148) · Drug: Rituximab

  • Experimental
    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.

    Drug: Evorpacept (ALX148) · Drug: Pembrolizumab · Drug: 5-FU + Cisplatin

  • Experimental
    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.

    Drug: Evorpacept (ALX148) · Drug: Trastuzumab · Drug: Ramucirumab + Paclitaxel

Interventions

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicities (Number of participants with a DLT)

    Number of participants with a DLT

    Time frame: Up to 28 days

07

Study locations

10 sites
  • 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
08

References and documents

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. PubMed 40207726 ↗
  • 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. PubMed 34793719 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Feb 2022, 59 months.

Of 286 industry-sponsored phase 1 interventional studies under Neoplasm Metastasis, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 75. This study's 59 months is above that.

Counting every sponsor, half of 496 studies reached it within 54 months; a quarter within 33 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2016
First posted
Jan 6, 2017
StartActual
Feb 3, 2017
Primary completionActual
Feb 1, 2022
CompletionActual
Jul 8, 2025
Last update
Aug 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03013218
Lead sponsor
ALX Oncology Inc.
Responsible party
Sponsor
First posted
Jan 6, 2017
Start date
Feb 3, 2017
Primary completion
Feb 1, 2022
Completion
Jul 8, 2025
Last update
Aug 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: ALX148

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