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

A

ALX Oncology

Status and phase

Active, not recruiting
Phase 2

Conditions

Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma

Treatments

Drug: evorpacept
Drug: pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04675294
AT148003
KEYNOTE-B87 (Other Identifier)
MK-3475-B87 (Other Identifier)
2020-004093-21 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment

189 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

189 participants in 2 patient groups

evorpacept (ALX148) + pembrolizumab
Experimental group
Description:
evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Treatment:
Drug: pembrolizumab
Drug: evorpacept
pembrolizumab
Active Comparator group
Description:
pembrolizumab 200 mg IV given every 3 weeks.
Treatment:
Drug: pembrolizumab

Trial contacts and locations

53

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Central trial contact

Harry Liu, MD, MPH, MBA

Data sourced from clinicaltrials.gov

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