Cohorts of patients with recurrent or metastatic (R/M) squamous cell cancer of the head and
neck (HNSCC) or advanced or metastatic cutaneous squamous cell carcinoma will receive
anti-PD1 therapy in combination with anti EGFR antibody-dye conjugate, ASP-1929, followed by
photoimmunotherapy (PIT). HNSCC patients are required to have positive expression of
programmed cell death ligand 1 (PD-L1) defined by Combined Positive Score (CPS) ≥1. Primary
endpoints are safety, tolerability, and tumor response of ASP-1929 PIT treatment in
combination with anti-PD1.
Overall Inclusion Criteria:
Provide written informed consent
• Cancers as follows:
Cohort 1 : Histologically or cytologically confirmed recurrent locally and/or metastatic
head and neck squamous cell carcinoma with Combined Positive Score (CPS) ≥ 1 as determined
by an FDA approved test
Note: A multi-disciplinary group (including a surgeon and radiation oncologist) must agree
that the patient is not a candidate for locoregional therapy.
Cohort 2 : Histologically or cytologically confirmed locally advanced or metastatic
cutaneous squamous cell carcinoma not amenable to definitive surgery or radiation.
Cohort 3: Histologically or cytologically confirmed locally advanced or metastatic
cutaneous squamous cell carcinoma not amendable to definitive surgery or radiation.
Patients' disease has progressed despite at least 2 months of anti-PD1 therapy.
- At least one site of disease accessible to light illumination
- Measurable disease by modified RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No prior systemic therapy administered in the recurrent and/or metastatic setting
(with the exception of systemic therapy completed ≥ 6 months prior if given as part of
multimodal treatment for locally advanced disease)
- Adequate organ function
- Female patients of childbearing potential must have a negative pregnancy test at
screening and must be willing to use 2 methods of highly effective birth control while
on study or be surgically sterile, or abstain from heterosexual sexual activity for
the course of the study through 120 days after the last dose of anti-PD1 treatment.
- Male participants must agree to use a highly effective method of contraception
starting with the first dose of study medication through 120 days after the last dose
of anti-PD1 treatment.
- Prior therapy with an anti-PD1 or anti-PD-L1 (Cohort 1 and 2 only)
- Radiation therapy (or other non-systemic therapy) within 4 weeks prior to study Day 1
or not fully recovered from adverse events due to a previously administered treatment
- Receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of
prednisone equivalent) or any other form of immunosuppressive therapy within 14 days
prior to Cycle 1 Day 1.
- Diagnosed and/or treated for additional malignancy within 2 years prior to study Day
1, except for, curatively treated basal cell carcinoma of the skin, squamous cell
carcinoma of the skin and/or curatively resected in situ cervical and/or breast
- History of significant (≥ Grade 3) cetuximab infusion reactions
- Prior allogeneic tissue/solid organ transplant
- Known or active central nervous system metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in past 2 years (ie,
with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Evidence of interstitial lung disease or current active, noninfectious pneumonitis
- Active infection requiring systemic therapy
- Known or active bacterial, viral, and fungal infection including tuberculosis, active
Hepatitis B (eg, HBsAg reactive), or Hepatitis C (eg, RNA [qualitative] is detected)
- Known history of testing positive for human immunodeficiency virus (HIV) or acquired
immunodeficiency syndrome (AIDS)-related illness
- Received a live vaccine within 30 days of study Day 1. Note: seasonal influenza
vaccines for injection are generally inactivated flu vaccines and are allowed; however
intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are
- Patients expecting to breastfeed during the study and through 120 days after the last
dose of study treatment
- Major surgery or significant traumatic injury ≤ 28 days before study day 1, or
anticipation of the need for major surgery during the course of study treatment.
- Currently participating or participated in a study of an investigational agent and
received study therapy (including RM-1929 or ASP-1929 PIT studies), or used an
investigational device within 4 weeks of study Day 1
- 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