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

NCT04305795 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Metastatic Head-and-neck Squamous-cell Carcinoma
  • Locally Advanced Cutaneous Squamous Cell Carcinoma
  • Metastatic Cutaneous Squamous Cell Carcinoma

Interventions

BIOLOGICAL

200 mg Pembrolizumab

every 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months.

BIOLOGICAL

350 mg Cemiplimab

every 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months.

COMBINATION_PRODUCT

ASP-1929 PIT

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.

Sponsors & Collaborators

  • Rakuten Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Toshiaki Suzuki, MD · Rakuten Medical, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305795 on ClinicalTrials.gov