Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma

Head Neck. 2021 Dec;43(12):3875-3887. doi: 10.1002/hed.26885. Epub 2021 Oct 9.


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 response rate (ORR) 43.3% (95% CI 25.46%-62.57%); confirmed ORR 26.7% (95% CI 12.28%-45.89%); median overall survival 9.30 months (95% CI 5.16-16.92 months).

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.

Keywords: RM-1929 photoimmunotherapy; cetuximab-IR700 conjugate; light-activatable dye (IRDye 700DX); recurrent head and neck squamous cell carcinoma (rHNSCC); tumor-targeted monoclonal antibody.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols
  • Cetuximab / therapeutic use
  • Head and Neck Neoplasms* / therapy
  • Humans
  • Immunotherapy*
  • Neoplasm Recurrence, Local* / drug therapy
  • Phototherapy
  • Squamous Cell Carcinoma of Head and Neck* / therapy


  • Cetuximab

Associated data