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

• ClinicalTrials.gov Identifier: NCT04675294
• Recruitment Status: Recruiting
• First Posted: December 19, 2020
• Last Update Posted: March 22, 2024
• Sponsor: ALX Oncology Inc.
• Collaborator: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): ALX Oncology Inc.

Tracking Information

• First Submitted Date: December 15, 2020
• First Posted Date: December 19, 2020
• Last Update Posted Date: March 22, 2024
• Actual Study Start Date: April 2, 2021
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 4, 2021)

• Objective response rate per RECIST 1.1 [ Time Frame: Last randomized patient reaching at least 24 weeks of follow-up ]
• 12-month overall survival rate [ Time Frame: Last randomized patient reaching 12 months of follow-up ]

• Original Primary Outcome Measures (submitted: December 15, 2020): Objective response rate per RECIST 1.1 [ Time Frame: Last randomized patient reaching at least 24 weeks of follow-up. ]

Current Secondary Outcome Measures (submitted: November 4, 2021)

• Duration of response [ Time Frame: Up to 36 months ]
• Progression-free survival [ Time Frame: Up to 36 months ]
• Overall survival [ Time Frame: Up to 36 months ]
• Adverse events [ Time Frame: Up to 36 months ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evorpacept (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)
• Brief Summary: A Phase 2 Study of evorpacept (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 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Drug: evorpacept
  IV Q3W
  Other Name: ALX148
• Drug: pembrolizumab
  IV Q3W
  Other Name: KEYTRUDA®

Study Arms

• Experimental: evorpacept (ALX148) + pembrolizumab
  evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
  Interventions:

  • Drug: evorpacept
  • Drug: pembrolizumab
• Active Comparator: pembrolizumab
  pembrolizumab 200 mg IV given every 3 weeks.
  Intervention: Drug: pembrolizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 4, 2021): 183
• Original Estimated Enrollment (submitted: December 15, 2020): 111
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Harry Liu, MD, MPH, MBA; 1 650.502.4697; info@alxoncology.com

• Listed Location Countries: Australia, Belgium, Canada, Korea, Republic of, Netherlands, Singapore, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT04675294
• Other Study ID Numbers: AT148003; KEYNOTE-B87 ( Other Identifier: Merck Sharp & Dohme LLC ); MK-3475-B87 ( Other Identifier: Merck Sharp & Dohme LLC ); 2020-004093-21 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ALX Oncology Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ALX Oncology Inc.
• Original Study Sponsor: Same as current
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Not Provided
• PRS Account: ALX Oncology Inc.
• Verification Date: February 2024