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New combo aims to tame HPV throat cancer with fewer side effects

NCT ID NCT07578467

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 09, 2026 · Updated 4 times

Summary

This early-phase trial tests whether a new drug (ATRN-119) combined with a single, precise dose of radiation to the neck can safely and effectively treat early-stage HPV-positive throat cancer before surgery. About 35 participants will take the drug daily for 10 days and receive one radiation treatment on day 3, followed by standard surgery. The goal is to reduce long-term side effects while keeping cure rates high.

What this could mean

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

Active substance
ATRN-119 (a drug that blocks a DNA repair protein called ATR) plus a single dose of highly targeted radiation (SBRT) to the neck lymph nodes
What this could lead to
If it works, this approach could offer a less toxic treatment option for early-stage HPV-positive throat cancer, potentially reducing long-term side effects while keeping cure rates high.
What could go wrong
This is an early-phase trial with only 35 participants, so results may not apply to everyone. The drug-radiation combo could cause unexpected side effects or fail to improve outcomes over standard care.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 35 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age ≥ 18 * Patients that have been diagnosed with HPV-positive throat cancer (OPSCC) at an early stage (stage I or II), confirmed by a biopsy. * Patients' blood calcium level is within a safe range * Patients' blood, kidney, and liver health are strong enough, shown through specific medical test results * If a participant is female, she must not be pregnant or breastfeeding. * If a participant is male, he must agree to use highly effective birth control from the start of the study until a short period after the last dose of the study drug. Exclusion Criteria: * Patients with late-stage tumors (Stage III or IV) * If the cancer has already spread to distant parts of the body (M1) when first diagnosed * Prior advanced head and neck cancer requiring radiation or major surgery * Patients whose original tumor site cannot be identified * Patients that have a known additional malignancy that is progressing or requires active treatment * Patients that had a surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119. This does not include procedures that are used to diagnose or determine extent of study disease (such as biopsies). * Patients taking medications that strongly affect how the body processes certain drugs (CYP enzymes) at the same time as the study treatment. * Patients with active infections and/or receiving systemic antibiotics or anti-viral medications. * Patients with uncontrolled HIV or active hepatitis B or C are usually not eligible. However, those whose infections are well-controlled on treatment for at least a month and meet certain viral load limits can participate * Current or past diagnosis of leukemia within the past 5 years. * Patients with a history of non-malignant gastrointestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months. * Patient has uncontrolled hypertension at time of enrollment. * Patients who recently had serious kidney problems or kidney disease. * Patients cannot have taken another experimental drug within 30 days-or within a period equal to five times that drug's half-life-before starting this study * Medical illness that, in the opinion of the Investigator, may impact the safety of the patient * Patients who use recreational drugs or have mental health conditions that might make it hard to follow study visits, based on the doctor's judgment. * Known hypersensitivity to ATRN-119 or its ingredients * Patients with serious liver disease or liver problems that could affect how the body processes the study drug * Patients who are fairly limited in daily activities (ECOG score of 2 or higher) * Patients with serious other health problems that the doctor thinks could prevent them from completing the study * Pregnancy or lactation * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.