Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT04305795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2020-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
Sponsor:
Rakuten Medical, Inc.
Organization:
Study Overview
Official Title:
An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: