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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS)
Secondary outcome measures
Complete Response (CR)
Complete Response by Biopsy (CRb)
Duration of Response (DoR)
+8 moreTrial 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
5 Previous Clinical Trials
152 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have finished radiation therapy aimed at curing cancer in my head or neck.You have experienced severe allergic reactions to cetuximab infusions in the past.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks and have recovered from any side effects.My tumor is affecting a major blood vessel but has been treated to prevent bleeding.I agree to use contraception for 6 months after my last treatment.I am being treated for or have been diagnosed with cancer, excluding nonmelanoma skin cancer or head and neck squamous cell carcinoma.My head or neck cancer has worsened after two treatments.I am not pregnant or breastfeeding and agree to use contraception for 6 months after treatment.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has worsened after platinum-based chemotherapy.I have been part of a trial for ASP-1929 or RM-1929 PIT before.I haven't had monoclonal antibody therapy in the last 4 weeks or still have side effects from it.My cancer has spread to distant parts of my body.My cancer in the head or neck area cannot be cured with surgery or radiation.My kidney function is not normal.I do not have any severe illnesses or social situations that would stop me from following the trial's requirements.All my head and neck tumors can be reached with light treatment.My liver isn't working properly.
Research Study Groups:
This trial has the following groups:- Group 1: ASP-1929 Photoimmunotherapy
- Group 2: Physician's Choice SOC
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has ASP-1929 Photoimmunotherapy been cleared by the FDA?
"There is some data supporting the efficacy of ASP-1929 Photoimmunotherapy and it has gone through multiple rounds of testing, so it received a score of 3."
Answered by AI
How many individuals are being assisted by this clinical trial?
"That is correct, the trial is still recruiting patients. According to the information on clinicaltrials.gov, the study was created on May 9th, 2019 and was last updated on March 26th, 2021. They are looking for 275 individuals total from 13 different locations."
Answered by AI
Are individuals with specific medical conditions able to participate in this research project?
"That is accurate. As the clinicaltrials.gov website attests, this trial is still looking for participants. This research was first advertised on May 9th, 2019 and was updated as recently as March 26th, 2021. In total, they are trying to find 275 people across 13 different sites."
Answered by AI
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