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

Part of paid clinical trials in Miami, Florida.

Sponsor
Rakuten Medical, Inc.
Study ID
NCT04305795
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 200 mg Pembrolizumab — BIOLOGICAL
    every 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months.
  • 350 mg Cemiplimab — BIOLOGICAL
    every 3 weeks on Days 1 and 22 of each 6-week cycle for up to 24 months.
  • ASP-1929 PIT — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Dec 21, 2020
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Sub-study 1- 1L HNSCC
    Recurrent locally advanced and/or metastatic head and neck squamous cell carcinoma
  • Other: Sub-study 2- 1L cuSCC
    Locally advanced or metastatic cutaneous squamous cell carcinoma
  • Other: Sub-study 3- 2L cuSCC
    Locally advanced or metastatic cutaneous squamous cell carcinoma

Primary Outcome Measure

Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy [ Time Frame: 24 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Miami Hospital and ClinicsMiamiFlorida33136-
University of KentuckyLexingtonKentucky40536-
Mayo ClinicRochesterMinnesota55905-
Providence Medical CenterPortlandOregon97213-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37203-
University of Texas, MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Miami, FL

By research site
University of Miami Hospital and Clinics· Miami, FLUniversity of Kentucky· Lexington, KYMayo Clinic· Rochester, MNProvidence Medical Center· Portland, ORThomas Jefferson University· Philadelphia, PAVanderbilt-Ingram Cancer Center· Nashville, TN

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