New combo aims to tame HPV throat cancer with fewer side effects
NCT ID NCT07578467
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
- MRI scans may reveal which throat cancer patients need stronger treatment
- Can an immunotherapy combo shrink sinonasal tumors before surgery?
- Can a DNA vaccine boost immunotherapy against HPV-Linked head and neck cancer?
- Can a laser microscope diagnose skin cancer faster?
- Can a shorter radiation course tame side effects in head and neck cancer?
- Can Pre-Surgery immunotherapy prime the immune system to fight head and neck cancer?