Clinical Trials /

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

NCT04675294

Description:

A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03).
  • Official Title: A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03).

Clinical Trial IDs

  • ORG STUDY ID: AT148003
  • SECONDARY ID: KEYNOTE-B87
  • NCT ID: NCT04675294

Conditions

  • Head and Neck Cancer
  • Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
ALX148ALX148 + Pembrolizumab
PembrolizumabKeytrudaALX148 + Pembrolizumab

Purpose

A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Detailed Description

      This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of
      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) who
      have not yet been treated for their advanced disease. The study comprises an initial safety
      lead-in cohort followed by a randomized portion.
    

Trial Arms

NameTypeDescriptionInterventions
ALX148 + PembrolizumabExperimentalALX148 45 mg/kg IV and pembrolizumab 200mg IV given every 3 weeks.
  • ALX148
  • Pembrolizumab
PembrolizumabActive ComparatorPembrolizumab 200mg IV given every 3 weeks.
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  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 & Liver Function.

          -  Adequate Performance Status

        Exclusion Criteria:

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate per RECIST 1.1
Time Frame:Last randomized patient reaching at least 24 weeks of follow-up.
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ALX Oncology Inc.

Trial Keywords

  • ALX148
  • CD47
  • SIRPα
  • HNSCC
  • Pembrolizumab

Last Updated

May 17, 2021