Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma.
Publication/Presentation Date
12-1-2021
Abstract
BACKGROUND: Recurrent head and neck squamous cell carcinoma (rHNSCC) represents a significant global health burden with an unmet medical need. In this study we determined the safety and efficacy of RM-1929 photoimmunotherapy in patients with heavily pretreated rHNSCC.
METHODS: RM-1929 (anti-EGFR-IR700 dye conjugate) was infused, followed by tumor illumination. We evaluated safety, tumor response, and pharmacokinetics.
RESULTS: Nine patients were enrolled in Part 1 (dose-finding) and 30 patients in Part 2 (safety and efficacy). No dose-limiting toxicities were experienced in Part 1; 640 mg/m
CONCLUSIONS: Treatment was well tolerated. Responses and survival following RM-1929 photoimmunotherapy in heavily pretreated patients with rHNSCC were clinically meaningful and warrant further investigation.
CLINICAL TRIAL INFORMATION: NCT02422979.
Volume
43
Issue
12
First Page
3875
Last Page
3887
ISSN
1097-0347
Published In/Presented At
Cognetti, D. M., Johnson, J. M., Curry, J. M., Kochuparambil, S. T., McDonald, D., Mott, F., Fidler, M. J., Stenson, K., Vasan, N. R., Razaq, M. A., Campana, J., Ha, P., Mann, G., Ishida, K., Garcia-Guzman, M., Biel, M., & Gillenwater, A. M. (2021). Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma. Head & neck, 43(12), 3875–3887. https://doi.org/10.1002/hed.26885
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
34626024
Department(s)
Administration and Leadership
Document Type
Article