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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

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

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.

02

Conditions studied

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

Keywords

  • Neoplasms
  • CD47
  • SIRPα
  • ALX148
  • Evorpacept
03

Who can participate

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

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

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.
04

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

  • DrugEvorpacept (ALX148)

    Evorpacept (ALX148)

  • DrugPembrolizumab

    Keytruda

  • DrugTrastuzumab

    Herceptin

  • DrugRituximab

    Rituxan

  • DrugRamucirumab + Paclitaxel

    Standard of care chemotherapy

  • Drug5-FU + Cisplatin

    Standard of care chemotherapy

05

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

06

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
07

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

08

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 ↗

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