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NCT Number: NCT03013218

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

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Key information

Conditions

Metastatic Cancer Advanced Cancer Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplastic Processes NonHodgkin Lymphoma Pathologic Processes Pathological Conditions, Signs and Symptoms Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital, Seongnam, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Evorpacept (ALX148)

Drug

Evorpacept (ALX148)

Pembrolizumab

Drug

Keytruda

Trastuzumab

Drug

Herceptin

Rituximab

Drug

Rituxan

Ramucirumab + Paclitaxel

Drug

Standard of care chemotherapy

5-FU + Cisplatin

Drug

Standard of care chemotherapy

Primary outcomes

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

    Time frame: Up to 28 days

    Number of participants with a DLT

Sponsors and collaborators

Lead sponsor

ALX Oncology Inc.

Industry

Registry information

Official study title

A Phase 1, Dose Escalation Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)

Important dates

Study start
2017
Primary completion
2022
Study completion
2025
First posted
Jan 6, 2017
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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