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Virus Therapy

Photoimmunotherapy for Head and Neck Cancer

Phase 3
Recruiting
Research Sponsored by Rakuten Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have completed prior curative radiation therapy for treatment of their head and neck region
Have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck.
Must not have
Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC
Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new drug, ASP-1929, against the current standard of care for head and neck cancer that has come back or progressed after two or more other treatments.

Who is the study for?
This trial is for adults with recurrent head and neck cancer who have tried at least two other treatments without success. They must be in relatively good health (ECOG score of 0 or 1), not pregnant, agree to use contraception, and have a life expectancy over six months. The cancer should be measurable by CT scan and accessible for treatment but not spread to distant areas or invading major blood vessels.
What is being tested?
The study compares ASP-1929 Photoimmunotherapy (PIT) with the physician's choice of standard care. Participants will either receive this new therapy that combines a drug with light exposure on the tumor area or get the usual treatment options available for their condition.
What are the potential side effects?
Specific side effects are not listed here, but generally, photoimmunotherapy like ASP-1929 could cause reactions related to light exposure on treated areas, typical chemotherapy side effects such as nausea, fatigue, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have finished radiation therapy aimed at curing cancer in my head or neck.
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My head or neck cancer has worsened after two treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has worsened after platinum-based chemotherapy.
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My cancer in the head or neck area cannot be cured with surgery or radiation.
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All my head and neck tumors can be reached with light treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am being treated for or have been diagnosed with cancer, excluding nonmelanoma skin cancer or head and neck squamous cell carcinoma.
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I have been part of a trial for ASP-1929 or RM-1929 PIT before.
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I haven't had monoclonal antibody therapy in the last 4 weeks or still have side effects from it.
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My cancer has spread to distant parts of my body.
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My kidney function is not normal.
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I do not have any severe illnesses or social situations that would stop me from following the trial's requirements.
Select...
My liver isn't working properly.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Progression-Free Survival (PFS)
Secondary study objectives
Complete Response (CR)
Complete Response by Biopsy (CRb)
Duration of Response (DoR)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ASP-1929 PhotoimmunotherapyExperimental Treatment1 Intervention
Use of ASP-1929 Photoimmunotherapy
Group II: Physician's Choice SOCActive Control1 Intervention
docetaxel, cetuximab, methotrexate, paclitaxel

Find a Location

Who is running the clinical trial?

Rakuten Medical, Inc.Lead Sponsor
6 Previous Clinical Trials
547 Total Patients Enrolled
Ethan Chen, MDStudy DirectorRakuten Medical
1 Previous Clinical Trials
408 Total Patients Enrolled
Sarah Arron, MDStudy DirectorRakuten Medical, Inc.
1 Previous Clinical Trials
24 Total Patients Enrolled
Naomi SchechterStudy DirectorRakuten Medical
1 Previous Clinical Trials

Media Library

ASP-1929 Photoimmunotherapy (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03769506 — Phase 3
Head and Neck Cancers Research Study Groups: ASP-1929 Photoimmunotherapy, Physician's Choice SOC
Head and Neck Cancers Clinical Trial 2023: ASP-1929 Photoimmunotherapy Highlights & Side Effects. Trial Name: NCT03769506 — Phase 3
ASP-1929 Photoimmunotherapy (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03769506 — Phase 3
~39 spots leftby Dec 2025
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