Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT04305795
Brief Summary:
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.
Detailed Description:
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:
NCT04305795
Study Brief:
Protocol Section:
NCT04305795