A Study of ALX148 in Patients With Advanced Solid Tumors and Lymphoma

Status: Active

Description

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

Eligibility Criteria

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.

Locations & Contacts

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Contact: Stephen Hodi
Email: FHODI@PARTNERS.ORG
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
Name Not Available

Trial Objectives and Outline

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 142 adult patients are expected to be enrolled in the study.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
ALX Oncology Inc.

Trial IDs

Primary ID AT148001
Secondary IDs NCI-2017-00378
Clinicaltrials.gov ID NCT03013218