A Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01)
Trial Status: Active
A phase 1, dose escalation study of ALX148 in patients with advanced solid tumors and lymphoma
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.
Colorado
Aurora
University of Colorado Hospital
Status: ACTIVE
Connecticut
New Haven
Yale University
Status: ACTIVE
Massachusetts
Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Frank Stephen Hodi
Phone: 617-632-5053
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Justin F. Gainor
Phone: 617-724-4000
Email:
jgainor@partners.org
Washington
Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
This phase 1 clinical study (AT148001) is an open-label, multi-center, multiple-dose, dose-escalation, safety, PK, and PD study of 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.
Trial Phase Phase I
Trial Type Treatment
Lead Organization
ALX Oncology Inc.
- Primary ID AT148001
- Secondary IDs NCI-2017-00378
- Clinicaltrials.gov ID NCT03013218