A phase I, single-center, open-label study of RM-1929 photoimmunotherapy in Japanese patients with recurrent head and neck squamous cell carcinoma.

ABSTRACT:

Background

To determine the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of a single cycle of RM-1929 photoimmunotherapy, an anti-EGFR antibody cetuximab conjugated with a light-activatable dye (IRDye^®700DX), in Japanese patients with recurrent head and neck squamous cell carcinoma (rHNSCC).

Methods

Patients received a single fixed dose (640 mg/m²) of RM-1929 and a fixed light treatment dose (50 J/cm² for superficial illumination; 100 J/cm fiber diffuser length for interstitial illumination). Safety, tumor response (modified RECIST v1.1 by central radiology review), pharmacokinetics, and immunogenicity were evaluated.

Results

Three Japanese patients were enrolled who had failed ≥ 3 prior lines of therapy including

SUBMITTER: Tahara M 

PROVIDER: S-EPMC8449763 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature