Clinical Trial Summary

---

Phase

Phase 3

---

Funding Agency/Sponsor

Industrial

---

Disease

Head and Neck Cancer

---

Enrollment Eligibility

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.
- Failed or progressed following prior platinum 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
agree 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 weeks 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

---