This study is in progress, not accepting new patients

Evorpacept (ALX148) in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

a study on Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Official Title

A Phase 2 Study of ALX148 in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Details

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Keywords

Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, ALX148, CD47, SIRPα, HNSCC, pembrolizumab, evorpacept, Carcinoma, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, evorpacept (ALX148) + pembrolizumab

Eligibility

Locations

  • University of California San Diego
    La Jolla California 92037 United States
  • Hoag Hospital
    Irvine California 92618 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ALX Oncology Inc.
ID
NCT04675294
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 189 people participating
Last Updated