Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumours

Official Title

A Phase 1, Multicentre, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab or Other Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumours

Summary:

This is a Phase 1 open-label, multicentre study of the safety and tolerability, immunogenic effects, antitumour activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab or other immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumours. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

Trial Description

Primary Outcome:

• Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
• Recommended Phase 2 dose (RP2D)
• Antitumour activity (Part 3 only)

• Antitumour activity (Parts 1 and 2)
• Manufacturing feasibility (Part 1 only)

View this trial on ClinicalTrials.gov