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An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

Recurrent Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

Clinical Trial Summary

Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.

Clinical Trial Description

Cohorts of patients with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC) or advanced or metastatic cutaneous squamous cell carcinoma (cuSCC) will receive anti-PD1 therapy in combination with anti EGFR antibody-dye conjugate, ASP-1929, followed by photoimmunotherapy (PIT). HNSCC patients are required to have positive expression of programmed cell death ligand 1 (PD-L1) defined by Combined Positive Score (CPS) ≥1. Primary endpoints are safety, tolerability, and tumor response of ASP-1929 PIT treatment in combination with anti-PD1. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Locally Advanced Cutaneous Squamous Cell Carcinoma
  • Metastatic Cutaneous Squamous Cell Carcinoma
  • Metastatic Head-and-neck Squamous-cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT04305795
Study type Interventional
Source Rakuten Medical, Inc.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date December 21, 2020
Completion date June 2025
View Details
See also
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