An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.

Inclusion Criteria:
• 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
• 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
• 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

Exclusion Criteria:
• 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 cancers
• 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
• 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 study requirements
Phase I/II
Oral, Head and Neck
R Bryan Bell, M.D.
Rakuten Medical, Inc. (formerly Aspyrian Therapeutics, Inc. and Rakuten Aspyrian, Inc.)
George Morris
  • Providence Cancer Institute Franz Clinic