ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Rakuten Medical, ASP-1929, PIT, Photoimmunotherapy, HNC, HNSCC, Head and neck, EGFR, Cetuximab, Erbitux, RM-1929 Read More

Overall Inclusion Criteria:

• Have a histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment
• Have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck, one of which must be prior systemic platinum-based chemotherapy
• Have completed prior curative radiation therapy for treatment of their head and neck region
• Have locoregional head and neck tumor site(s) that are all accessible to illumination
• Have target tumors that are clearly measurable by contract enhanced CT scan
• Have a life expectancy of > 6 months, based on Investigator judgment
• Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
• Female patients of childbearing potential must not be pregnant or breastfeeding and agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of trial intervention and must refrain from breastfeeding for at least 2 months after the last ASP-1929 infusion
• Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

Overall Exclusion Criteria:

• Have a history of significant (> Grade 3) cetuximab infusion reactions
• Have been treated with prior systematic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or not recovered from adverse events due to a previously administered agent
• Have been treated with an anticancer monoclonal antibody therapy within 4 of trial Day 1 or have not recovered from adverse events due to previously administered agent
• Have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or have not recovered from adverse events, due to previously administered agent or intervention
• Have a present history of distant metastatic disease (M1)
• Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC
• Have a tumor in enhanced CT or MRI scan invading a major blood vessel, unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel
• Have impaired hepatic function
• Have impaired renal function
• Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with trial requirements
• Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment