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Metastatic CancerPhase 1NCT03013218

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

A Phase 1 study testing Evorpacept (ALX148), Pembrolizumab and Trastuzumab in people with Metastatic Cancer and Solid Tumor, run by ALX Oncology Inc. at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer, Solid Tumor, Advanced Cancer
What is being tested?
Evorpacept (ALX148), Pembrolizumab and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
10 sitesin 2 countries
Study dates
3 Feb 2017to 8 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Colorado Denver

    Denver, Colorado, 80045

  • START-Midwest

    Grand Rapids, Michigan, 49503

  • Yale University

    New Haven, Connecticut, 06520

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 1, Dose Escalation 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

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.

Being tested
Evorpacept (ALX148), Pembrolizumab, Trastuzumab, Rituximab, Ramucirumab + Paclitaxel
Keywords
Neoplasms, CD47, SIRPα, ALX148, Evorpacept
Medical subject headings
Neoplasm Metastasis, Lymphoma, Non-Hodgkin, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evorpacept (ALX148)Drug

    Evorpacept (ALX148)

  • PembrolizumabDrug

    Keytruda

  • TrastuzumabDrug

    Herceptin

  • RituximabDrug

    Rituxan

  • Ramucirumab + PaclitaxelDrug

    Standard of care chemotherapy

  • 5-FU + CisplatinDrug

    Standard of care chemotherapy

Study groups in NCT03013218
Study groupRoleWhat they receive
Evorpacept (ALX148)ExperimentalThe Part 1 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks.
Receives: Drug: Evorpacept (ALX148)
Evorpacept (ALX148) + PembrolizumabExperimentalThe Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab infusions.
Receives: Drug: Evorpacept (ALX148); Drug: Pembrolizumab
Evorpacept (ALX148) + TrastuzumabExperimentalThe Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab infusions.
Receives: Drug: Evorpacept (ALX148); Drug: Trastuzumab
Evorpacept (ALX148) + RituximabExperimentalThe Part 2 Dose Escalation/Expansion: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with rituximab infusions.
Receives: Drug: Evorpacept (ALX148); Drug: Rituximab
Evorpacept (ALX148) + Pembrolizumab + 5FU + PlatinumExperimentalThe Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with pembrolizumab + 5FU + platinum infusions.
Receives: Drug: Evorpacept (ALX148); Drug: Pembrolizumab; Drug: 5-FU + Cisplatin
Evorpacept (ALX148) + Trastuzumab + Ramucirumab + PaclitaxelExperimentalThe Part 2 Dose Escalation: Evorpacept (ALX148) infusions will be administered weekly or every two weeks in combination with trastuzumab + ramucirumab + paclitaxel infusions.
Receives: Drug: Evorpacept (ALX148); Drug: Trastuzumab; Drug: Ramucirumab + Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of participants with a DLT

    Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2017 (estimated)
  2. Study start3 Feb 2017
  3. Primary completion1 Feb 2022
  4. Study completion8 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03013218
Sponsor's protocol ID
AT148001
Status last verified
Jul 2025
First submitted
15 Dec 2016
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Evorpacept (ALX148), Pembrolizumab and Trastuzumab in people with Metastatic Cancer and Solid Tumor, run by ALX Oncology Inc. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (Number of participants with a DLT) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03013218, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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