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Virus Therapy

Photoimmunotherapy for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Vassiliki Saloura, MD

Research Sponsored by Rakuten Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of screening

Documentation of histologically confirmed, resectable (by standard of care surgery), primary or recurrent locoregional HNSCC or cuSCC

Must not have

Tumor invading major blood vessel unless the vessel has been embolized or surgically ligated to prevent hemorrhage; must not have involvement of the common or internal carotid arteries defined as invasion, encasement or direct contact (lack of a radiographically visible plane between the tumor and carotid artery)

Any contraindications for CT or 18FDG PET/CT imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects of a new cancer treatment and how well it works in patients with head and neck or skin cancer.

Who is the study for?

This trial is for adults with resectable head and neck or cutaneous squamous cell carcinoma. Candidates must have a tumor that can be illuminated and imaged, no distant metastasis, not use photosensitizing drugs, and have good organ function. Women of childbearing age must test negative for pregnancy and agree to birth control; men must also agree to contraception.

What is being tested?

The study tests ASP-1929 Photoimmunotherapy (PIT) in patients with operable primary or recurrent head/neck or skin cancer. It's an open-label, single-arm Phase 2 trial focusing on the effects of PIT when used before standard surgery.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions similar to other immunotherapies such as allergic responses, inflammation at the treatment site, general discomfort or pain related to illumination procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My head, neck, or skin cancer is confirmed and can be removed with surgery.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tumor is not affecting my major blood vessels or carotid arteries.

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I have no health issues that prevent me from having CT or PET scans.

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I have tested positive for HIV/AIDS.

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I haven't had cancer treatment or been in a trial for any new drugs within the last 4 weeks.

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My cancer is not in my brain, skull base, central nervous system, or eye area.

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I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery unrelated to this study.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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My cancer has spread to distant parts of my body.

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I am taking medication that increases my skin's sensitivity to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathologic Tumor Response

Secondary study objectives

Local relapse rate

Overall Survival

Progression-free Survival (PFS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

ASP-1929 640 mg/m\^2 treatment by intravenous (IV) infusion followed approximately 24 hours later by illumination (also termed as photoimmunotherapy \[PIT\]) of tumor(s) using the PIT690 Laser System with a 690 nm light dose of 50 J/cm\^2 for superficial illumination and 100 J/cm of diffuser length for interstitial illumination. During the illumination procedure, fluorescence of the IR700 component of ASP-1929 will be imaged with a Shimadzu Fluorescence Imaging System camera. Patients will undergo standard of care surgery with or without chemotherapy or radiation approximately 21 days after ASP-1929 PIT treatment.

0 / 12Eligibility criteria met