作者
David M Cognetti, Jennifer M Johnson, Joseph M Curry, Samith T Kochuparambil, Darren McDonald, Frank Mott, Mary J Fidler, Kerstin Stenson, Nilesh R Vasan, Mohammad A Razaq, John Campana, Patrick Ha, Grace Mann, Kosuke Ishida, Miguel Garcia‐Guzman, Merrill Biel, Ann M Gillenwater
发表日期
2021/12
期刊
Head & neck
卷号
43
期号
12
页码范围
3875-3887
出版商
John Wiley & Sons, Inc.
简介
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/m2 with fixed light dose (50 J/cm2 or 100 J/cm) was recommended for Part 2. Adverse events (AEs) in Part 2 were mostly mild to moderate but 19 (63.3%) patients had AE ≥Grade 3, including 3 (10.0%) with serious AEs leading to death (not treatment related). Efficacy in Part 2: unconfirmed objective …
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