Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs (NCT07578467) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs
35 participantsStarted 2026-05-31
Plain-language summary
This research study is testing whether a new study drug (called ATRN-119) is safe and effective when combined with a single, highly targeted dose of radiation therapy (called stereotactic body radiation therapy or SBRT) to treat early-stage throat cancer that is caused by HPV.
The goal of this study is to treat cancer effectively while reducing side effects and helping patients maintain a better quality of life over the long term. Researchers hope that this approach will be just as successful-or possibly more successful-than current treatments, which already have high cure rates.
Participants will:
* Take 800mg of ATRN-119 every day for 10 days
* Receive 1 treatment (called a "fraction") of SBRT to the neck on day 3 of ATRN-119 dosing.
* Keep a short diary to track ATRN-119 dosing. The diary will be provided by study team
* Receive standard of care treatment after treatment with ATRN-119 + SBRT including TransOral Robotic Surgery (TORS) to remove the primary tumor with Neck Dissection and adjuvant therapy (if indicated)
* Receive additional safety checkups and tests by researchers during routine visits with their cancer doctor for 2 years after study treatment
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 usua…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS
Timeframe: Within 6 weeks after study treatment
2
Phase II: Major pathologic response (MPR) rate of radiated nodal disease
Timeframe: Immediately after standard of care primary tumor removal surgery