Rakuten Medical to start phase 3 trial of Alluminox treatment using ASP-1929 for head and neck cancer
This ASP-1929-301 study is currently underway in several countries such as the US and Taiwan, and will enroll 275 patients globally including Indian patients
Rakuten Medical, a company developing and commercialising precision, cell-targeting therapies based on its proprietary Alluminox platform, announced that the company has been granted permission from the Indian Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical trial (ASP-1929-301/ClinicalTrials.gov Identifier: NCT03769506) evaluating Alluminox treatment (photoimmunotherapy) using ASP-1929 in patients with locoregional, recurrent head and neck squamous cell carcinomas (HNSCC) in India, and the registration of clinical trial information with the Clinical Trial Registry of India (CTRI) has been completed (CTRI Identifier: CTRI/2023/05/052728).
The study sites will include medical institutions in India such as the Tata Memorial Centre and Narayana Health and the treatment will be administered to enrolled patients once ready. This ASP-1929-301 study is currently underway in several countries such as the US and Taiwan, and will enroll 275 patients globally including Indian patients.
The multi-centre, randomised, open-label, global Phase 3 study of Alluminox treatment using ASP-1929 will evaluate the efficacy and safety of ASP-1929 in patients with locoregional, recurrent HNSCC who have previously failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy, and are not eligible for surgery or radiation. Participants will be randomised to receive experimental therapy or investigator’s choice of systemic therapy (2:1). The dual-primary endpoints of the study are progression-free survival and overall survival, and a key secondary endpoint includes objective response rate.