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

You can join if…

Open to people ages 18 years and up

  • Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior systemic therapy for their advanced disease.
  • Adequate bone marrow function.
  • Adequate renal and liver function.
  • Adequate ECOG performance status.

You CAN'T join if...

  • Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
  • History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Prior treatment with any anti-CD47 or anti-SIRPα agent.
  • Prior treatment with anti-PD-1 or PD-L1.

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ALX Oncology Inc.
ID
NCT04675294
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 183 study participants
Last Updated