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Light-Activated drug combo takes on recurrent head and neck cancer in major trial

NCT ID NCT06699212

Disease control Sponsor: Rakuten Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a new treatment called ASP-1929 photoimmunotherapy (a light-activated drug) combined with the immunotherapy pembrolizumab works better than standard care for people with recurrent head and neck cancer that hasn't spread to other parts of the body. About 412 participants will be randomly assigned to receive either the new combination or standard treatment (pembrolizumab alone or with chemotherapy). The main goal is to see if the new combination helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ASP-1929 photoimmunotherapy (cetuximab sarotalocan) plus pembrolizumab
What this could lead to
If it works, this could offer a new first-line treatment option for people with recurrent head and neck cancer that hasn't spread, potentially improving survival.
What could go wrong
This is a phase 3 trial, but the combination is experimental. It may not prove better than current treatments, and photoimmunotherapy can cause side effects like pain, swelling, or skin reactions at the treatment site.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 412 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer \[AJCC\], other than nasopharynx or cuSCC). * Appropriate for SOC first-line treatment of their recurrent head and neck cancer with pembrolizumab ± chemotherapy. * No known history of any distant metastatic disease (M1 by AJCC eighth edition). * Tumors with at least one PIT-accessible and RECIST 1.1 measurable lesion as assessed by investigator. * Anti-PD-1 and anti-PD-L1-treatment naïve. * Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test * Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of screening * Adequate hematologic, renal, and hepatic organ function * Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and must be willing to use a highly effective birth control while on study or be surgically sterile or abstain from heterosexual sexual activity for the course of the study through 180 days after the last dose of study treatment. Male patients 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 study treatment. Exclusion Criteria: * Diagnosed and/or treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor. * 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 * Life expectancy of less than 3 months * Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Evidence of interstitial lung disease or current active, noninfectious pneumonitis * Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention * Known or active bacterial, viral, or fungal infection including tuberculosis, Hepatitis B (e.g., HBV DNA is detected), or Hepatitis C (e.g., RNA \[qualitative\] is detected) * Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS)-related illness * Prior or ongoing Grade ≥ 3 tumor hemorrhage within 12 weeks of randomization * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent * Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from AEs due to previously administered agent * Prior receipt of ASP-1929 at any time * Receiving chronic systemic steroid therapy (in doses exceeding 10 mg per day of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to randomization * Received a live vaccine within 4 weeks of randomization; seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed * Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment exposing the patient to significant light (e.g., eye examinations, surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment * Major surgery or significant traumatic injury within 4 weeks before randomization, or anticipation of the need for major surgery during the course of study treatment

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aichi Cancer Center

    RECRUITING

    Aichi, 464-8681, Japan

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

    Contact Email: •••••@•••••

  • Chi Mei Hospital

    RECRUITING

    Tainan, 736402, Taiwan

  • China Medical University

    RECRUITING

    Taichung, 404327, Taiwan

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, 734-8551, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807377, Taiwan

  • Kyoto Prefectural University of Medicine

    RECRUITING

    Kyoto, 602-8566, Japan

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan City, 333423, Taiwan

  • MacKay Memorial Hospital

    RECRUITING

    Taipei, 104217, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100225, Taiwan

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407219, Taiwan

  • Taipei Municipal Wanfang Hospital

    RECRUITING

    Taipei, 116081, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tokyo Medical University Hospital

    RECRUITING

    Tokyo, 160-0023, Japan

  • Tottori University Hospital

    RECRUITING

    Yonago, 683-8504, Japan

  • University of Kentucky Medical Center

    WITHDRAWN

    Lexington, Kentucky, 40536, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Texas, MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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