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

NCT04305795 | Active Not Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: ASP-1929-181
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

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.

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

Keywords

Rakuten Medical; ASP-1929; HNSCC; CUSCC; head and neck; cutaneous; squamous cell carcinoma; photoimmunotherapy; PIT; skin; EGFR; Anti-PD1; Pembrolizumab; Cemiplimab

Outcome Measures

Primary Outcomes (3)

• Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy

  Treatment Emergent Adverse Events (TEAE) and Serious TEAE

  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

  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

  24 months

Secondary Outcomes (4)

• Overall Survival (OS)

  24 months

• Progression-free survival (PFS)

  24 months

• Duration of Response (DOR)

  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

  24 months

Study Arms (3)

Sub-study 1- 1L HNSCC

OTHER

Recurrent locally advanced and/or metastatic head and neck squamous cell carcinoma

Biological: 200 mg Pembrolizumab; Combination Product: ASP-1929 PIT

Sub-study 2- 1L cuSCC

OTHER

Locally advanced or metastatic cutaneous squamous cell carcinoma

Biological: 350 mg Cemiplimab; Combination Product: ASP-1929 PIT

Sub-study 3- 2L cuSCC

OTHER

Locally advanced or metastatic cutaneous squamous cell carcinoma

Biological: 350 mg Cemiplimab; Combination Product: ASP-1929 PIT

Interventions

200 mg Pembrolizumab BIOLOGICAL

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

Sub-study 1- 1L HNSCC

350 mg Cemiplimab BIOLOGICAL

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

Sub-study 2- 1L cuSCC; Sub-study 3- 2L cuSCC

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.

Sub-study 1- 1L HNSCC; Sub-study 2- 1L cuSCC; Sub-study 3- 2L cuSCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent
• Cancers as follows:
• Sub-study 1: Histologically or cytologically confirmed recurrent locally and/or metastatic head and neck squamous cell carcinoma with Combined Positive Score (CPS) ≥ 1 as determined by a CLIA certified and/or FDA approved test.
• Note: A multi-disciplinary group (including a surgeon and radiation oncologist) must agree that the patient is not a candidate for locoregional therapy.
• Sub-study 2: Histologically or cytologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma not amenable to definitive surgery or radiation.
• Sub-study 3: Histologically or cytologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma not amendable to definitive surgery or radiation.
• At least one site of disease accessible to light illumination.
• Measurable disease by modified RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• No prior systemic therapy administered in the recurrent and/or metastatic setting (with the exception of systemic therapy completed ≥ 6 months prior if given as part of multimodal treatment for locally advanced disease). (Sub-study 1 only).
• Patients must be actively receiving single-agent, systemic anti-PD1 therapy at the time of screening (Sub-study 3 only).
• Disease progression despite at least 2 months of anti-PD1 therapy at the time of screening. Progression must be confirmed by at least two scans at least one month apart. Screening scan may serve as confirmation of progression (Sub-study 3 only).
• Adequate organ function.
• Female patients of childbearing potential must have a negative pregnancy test at screening and must be willing to use 2 methods of highly effective birth control while on study or be surgically sterile, or abstain from heterosexual sexual activity for the course of the study through 120 days after the last dose of anti-PD1 treatment.
• Male participants must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of anti-PD1 treatment.

You may not qualify if:

• Prior therapy with an anti-PD1 or anti-PD-L1 (Sub-study 1 only).
• Prior systemic therapy that is not intended as part of definitive treatment (eg, induction, concurrent, adjuvant, or neoadjuvant treatment) (Sub-studies 1 and 2 only).
• Systemic anti-PD-1 therapy prior to current course of definitive therapy (Sub-study 3 only).
• Prior systemic therapy given as definitive treatment (chemotherapy, EGFR inhibition). Patients with a history of prior chemoradiation are eligible (Sub-study 3 only).
• Radiation therapy (or other non-systemic therapy) within 4 weeks prior to study Day 1 or not fully recovered from adverse events due to a previously administered treatment
• Receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to Cycle 1 Day 1.
• Diagnosed and/or treated for additional malignancy within 2 years prior to study Day 1, except for, curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.
• History of significant (≥ Grade 3) cetuximab infusion reactions.
• Prior allogeneic tissue/solid organ transplant.
• Known or active central nervous system metastases and/or carcinomatous meningitis.
• Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
• Evidence of interstitial lung disease or current active, noninfectious pneumonitis.
• Active infection requiring systemic therapy.
• Known or active bacterial, viral, and fungal infection including tuberculosis, active Hepatitis B (eg, HBsAg reactive), or Hepatitis C (eg, RNA \[qualitative\] is detected)
• Known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.

Sponsors & Collaborators

• Rakuten Medical, Inc.: lead

Study Sites (7)

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Providence Medical Center

Portland, Oregon, 97213, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37203, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Interventions

pembrolizumab; cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Toshiaki Suzuki, MD

  Rakuten Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 12, 2020
• Study Start: December 21, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (7)