On December 23, 2020 Rakuten Medical, Inc. (Rakuten Medical) reported that their Phase 1b/2 clinical trial, an Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors (ClinicalTrials.gov Identifier: NCT04305795) has enrolled and treated its first patient in the United States, at The University of Texas MD Anderson Cancer Center, Houston, Texas (Press release, Rakuten Medical, DEC 23, 2020, View Source [SID1234573239]). Approximately 74 patients are planned for this trial in Head and Neck Squamous Cell Carcinoma (HNSCC) and Cutaneous Squamous Cell Carcinoma (CuSCC).

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The trial will enroll three cohorts of patients within distinct populations – all with locally advanced, recurrent and/or metastatic HNSCC or locally advanced or metastatic CuSCC. Primary endpoints of this study include safety, tolerability, and tumor response of the ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy.

"This trial is part of our commitment to develop ASP-1929 as part of our proprietary Illuminox platform for advancing treatment in HNSCC, as well as expanding into CuSCC," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "Based on the approval of ASP-1929 by the MHLW in Japan, we are hopeful in this latest expansion into CuSCC as part of our lifecycle management strategy."