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Virus Therapy

Photoimmunotherapy for Head and Neck Cancer

Phase 2
Recruiting
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
Female patients of childbearing potential must not be pregnant (confirmed by negative pregnancy test [urine or serum] at screening) or breastfeeding and must be willing to use a method of highly effective birth control, or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I am not pregnant or breastfeeding and agree to use birth control or abstain from sex during the study and for 60 days after.
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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.
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I have a tumor that can be reached with light therapy and seen on a special camera.
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I can provide a recent tumor sample for the study.
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My recent lab tests show my organs are functioning well.
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I am a male and will use birth control or abstain from sex during and for 60 days after the study.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic Tumor Response
Secondary outcome measures
Local relapse rate
Overall Survival
Progression-free Survival (PFS)
+6 more

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 portion 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.

Find a Location

Who is running the clinical trial?

Rakuten Medical, Inc.Lead Sponsor
5 Previous Clinical Trials
405 Total Patients Enrolled
Shimadzu CorporationUNKNOWN
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,325 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is ASP-1929 Photoimmunotherapy a safe and reliable treatment for individuals?

"With limited efficacy data, but some safety evidence already gathered, our team at Power rated ASP-1929 Photoimmunotherapy a 2 on the 1 to 3 scale."

Answered by AI

What is the current participation level in this research endeavor?

"Affirmative. Clinicaltrials.gov contains evidence that this research, which commenced on January 21st 2022, is actively recruiting participants. 22 individuals are being sought to take part in the experiment at one particular site."

Answered by AI

Is this experiment currently recruiting participants?

"As evidenced by clinicaltrials.gov, this medical study has opened up recruitment and is actively looking for volunteers. Its listing was initially posted on January 21st 2022 with the latest update occurring on May 23rd 2022."

Answered by AI
~6 spots leftby Mar 2025