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

Launched by RAKUTEN MEDICAL, INC. · Mar 11, 2020

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called ASP-1929 photoimmunotherapy combined with an existing therapy known as anti-PD1 for patients with advanced skin and head and neck cancers. The goal is to see if this combination can help treat patients who have recurrent or metastatic squamous cell carcinoma, which means their cancer has come back or spread to other parts of the body. The trial is currently active but not recruiting new participants.

To be eligible for this study, patients must have specific types of diagnosed cancers and have disease that can be reached by light treatment. They should also be in reasonably good health, meaning they can perform daily activities with little difficulty. Participants will receive the new treatment and be monitored closely for any effects. It's important to note that patients must follow strict guidelines on previous treatments and health conditions to join, and they need to understand the potential risks and benefits of participating in the trial.

Gender

ALL

Eligibility criteria

• Overall Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • Received a live vaccine within 30 days of study Day 1. Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed.
• • Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment cycle exposing the patient to significant light (eg, eye examinations, surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment
• • Patients expecting to breastfeed during the study and through 120 days after the last dose of study treatment.
• • Major surgery or significant traumatic injury ≤ 28 days before study day 1, or anticipation of the need for major surgery during the course of study treatment.
• • Currently participating or participated in a study of an investigational agent and received study therapy (including RM-1929 or ASP-1929 PIT studies), or used an investigational device within 4 weeks of study Day 1.
• • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.