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.
This basket trial study has 3 sub-studies: Sub-study 1 (181 HNSCC) will enroll patients with recurrent or metastatic (R/M) squamous cell cancer of the head and neck (HNSCC). HNSCC patients are required to have positive expression of programmed cell death ligand 1 (PD-L1) defined by Combined Positive Score (CPS) ≥1. Sub-study 2 (181 cuSCC) will enroll patients with locally advanced or metastatic cutaneous squamous cell carcinoma (cuSCC). Sub-study 3 (181 2LcuSCC) will enroll patients with locally advanced or metastatic cutaneous squamous cell carcinoma who have progressed on anti-PD-1 therapy. Eligible patients will enroll in the applicable sub-study and receive ASP-1929 photoimmunotherapy (PIT) treatment in combination with an anti-PD-1 therapy for up to 24 months. During the treatment period, patients will undergo clinical assessments and be monitored for safety and tolerability and disease progression by modified RECIST 1.1 for overall response rate (ORR), progression-free survival (PFS), and duration of response (DOR). Each sub-study is an open-label, single-arm study. For each sub-study, the primary objectives are to characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD-1 treatment and to assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
every 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months.
every 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months.
ASP-1929 IV on Day 8 of each 6-week cycle for up to 24 months. Photoimmunotherapy Light Treatment on Day 9 of each 6-week cycle for up to 24 months.
University of Miami Hospital and Clinics
Miami, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
Providence Medical Center
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy
Treatment Emergent Adverse Events (TEAE) and Serious TEAE
Time frame: 24 months
HNSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response
Objective Response Rate (ORR) per modified RECIST 1.1, as assessed by investigator
Time frame: 24 months
cuSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response
Objective Response Rate (ORR) per modified RECIST 1.1, by central review of tumor imaging by photography and radiographic assessments
Time frame: 24 months
Overall Survival (OS)
Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival
Time frame: 24 months
Progression-free survival (PFS)
Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival
Time frame: 24 months
Duration of Response (DOR)
Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on survival
Time frame: 24 months
cuSCC: Objective Response Rate (ORR) per modified RECIST 1.1, as assessed by investigator review of tumor imaging by photography and radiographic assessments
Assess the effect of ASP-1929 PIT treatment in combination with anti-PD1 therapy on tumor response
Time frame: 24 months
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