Study on ASP-1929 Photoimmunotherapy with Anti-PD1 Therapy for Advanced Solid Tumors Expressing EGFR
Sponsor: Rakuten Medical, Inc.
ClinicalTrials ID:NCT04305795
This clinical trial is exploring a new treatment combining ASP-1929 photoimmunotherapy with anti-PD1 therapy for patients with advanced head and neck or skin cancers that express EGFR. The study aims to assess the safety and effectiveness of this combination in controlling cancer.
Patient Parameters
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Program Overview
This study is testing a new treatment approach for patients with advanced cancers that express a protein called EGFR. The treatment combines ASP-1929 photoimmunotherapy with anti-PD1 therapy. It is designed for patients with recurrent or metastatic head and neck squamous cell cancer or advanced skin squamous cell carcinoma. The study will evaluate how safe and effective this combination is in reducing tumors and controlling the disease.
Description
The study is divided into three parts, each focusing on different patient groups:
- Sub-study 1: Includes patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) who have a specific protein marker (PD-L1) on their cancer cells.
- Sub-study 2: Includes patients with advanced or metastatic skin squamous cell carcinoma (cuSCC) that cannot be treated with surgery or radiation.
- Sub-study 3: Includes patients with advanced or metastatic skin squamous cell carcinoma who have not responded to previous anti-PD1 therapy.
Participants will receive ASP-1929 photoimmunotherapy combined with anti-PD1 therapy for up to 24 months. The study will monitor the safety and effectiveness of the treatment, focusing on how well it controls the cancer and how long the response lasts. Each part of the study is open-label, meaning both doctors and patients know what treatment is being given. The main goals are to understand the safety of the treatment and its impact on tumor response.
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent.
- Have specific types of cancer:
- Sub-study 1: Recurrent or metastatic head and neck squamous cell carcinoma with a PD-L1 score of 1 or higher.
- Sub-study 2: Advanced or metastatic skin squamous cell carcinoma not treatable with surgery or radiation.
- Sub-study 3: Advanced or metastatic skin squamous cell carcinoma not responding to anti-PD1 therapy.
- Have at least one tumor site that can be treated with light.
- Have measurable disease by standard criteria.
- Be in good overall health with a performance status of 0 or 1.
- No prior systemic therapy for recurrent/metastatic cancer, except if completed over 6 months ago for locally advanced disease (Sub-study 1).
- Be currently receiving anti-PD1 therapy (Sub-study 3).
- Show disease progression after at least 2 months of anti-PD1 therapy (Sub-study 3).
- Have adequate organ function.
- Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 120 days after the last anti-PD1 dose.
- Men must agree to use effective contraception during the study and for 120 days after the last anti-PD1 dose.
Exclusion Criteria
- Previous anti-PD1 or anti-PD-L1 therapy (Sub-study 1).
- Previous systemic therapy not part of definitive treatment (Sub-studies 1 and 2).
- Previous systemic anti-PD1 therapy before current definitive treatment (Sub-study 3).
- Recent radiation therapy or unresolved side effects from past treatments.
- Use of high-dose steroids or immunosuppressive therapy recently.
- Recent diagnosis or treatment for another cancer, except certain skin or cervical cancers.
- History of severe reactions to cetuximab.
- Previous organ transplant.
- Active brain metastases or meningitis.
- Active autoimmune disease needing treatment in the past 2 years.
- Lung disease or active pneumonitis.
- Active infection needing treatment.
- Positive for certain infections like hepatitis or HIV.
- Recent live vaccine.
- Need for procedures involving significant light exposure soon after treatment.
- Pregnant or breastfeeding women.
- Recent major surgery or injury.
- Participation in another study recently.
- Uncontrolled health conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami Hospital and Clinics | 33136 | Miami | Florida |
| University of Kentucky | 40536 | Lexington | Kentucky |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Providence Medical Center | 97213 | Portland | Oregon |
| Thomas Jefferson University | 19107 | Philadelphia | Pennsylvania |
| Vanderbilt-Ingram Cancer Center | 37203 | Nashville | Tennessee |
| University of Texas, MD Anderson Cancer Center | 77030 | Houston | Texas |
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