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HPV Positive Oropharyngeal Squamous Cell CarcinomaPhase 1/2NCT07578467

Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs

A Phase 1/2 study testing ATRN-119 and Stereotactic Body Radiation Therapy (SBRT) in people with HPV Positive Oropharyngeal Squamous Cell Carcinoma and Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ATRN-119 and Stereotactic Body Radiation Therapy (SBRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
31 Jan 2027to 31 Aug 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 22Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nick Lukens, MD contact

215-662-6567

RadOncCRU@PennMedicine.upenn.edu

Casey Hanna contact

215 - 615 - 1611

casey.hanna@pennmedicine.upenn.edu

About this study

Official title: A Phase Ib/II Study Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs

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.

Read more

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
Being tested
ATRN-119, Stereotactic Body Radiation Therapy (SBRT)
Medical subject headings
Carcinoma, Squamous Cell, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATRN-119Drug

    ATRN-119 at 800 mg QD (every day) for 10 days

  • Stereotactic Body Radiation Therapy (SBRT)Radiation

    10 Gy administered to nodal disease (neck) only on day 3 of ATRN-119 dosing

Study groups in NCT07578467
Study groupRoleWhat they receive
Treatment ArmExperimentalPatients will take 800mg of ATRN-119 every day for 10 days. On day 3 of dosing, they will return to clinic for 1 fraction of SBRT.
Receives: Drug: ATRN-119; Radiation: Stereotactic Body Radiation Therapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS

    This will be judged by whether patients are able to have their planned surgery within 6 weeks after the study treatment, and whether there are no problems during surgery that the study doctor believes were caused by the study treatment.

    Measured: Within 6 weeks after study treatment

  2. Phase II: Major pathologic response (MPR) rate of radiated nodal disease

    Researchers will measure how many patients have a strong treatment response in the affected lymph nodes that were treated with radiation, based on what is seen when the tissue is examined.

    Measured: Immediately after standard of care primary tumor removal surgery

Secondary outcomes (5)

  1. Phase II: To assess safety of ATR inhibitor ATRN-119 with nodal SBRT prior to surgery

    This will be judged based on whether there are any surgery problems that the study doctor thinks were caused by the earlier treatment, as well as any side effects from the treatment.

    Measured: From start of study treatment through standard of care 2-year Follow-Up visit

  2. Phase II: Radiographic response rates

    This looks at how many patients' tumors shrink or improve based on imaging tests like scans. This is assessed by comparing pre- and post- study treatment MRI (or CT) Neck scans using typical descriptive changes noted by a head and neck specialized radiologist.

    Measured: Pre-treatment MRI will be taken prior to enrollment as part of standard of care. Post-treatment Research MRI will be completed 1 week before standard of care tumor removal surgery.

  3. Phase II: Type of adjuvant treatment required

    Percentage of patients requiring additional radiation therapy +/- chemotherapy after their main treatment as compared to historic controls (e.g. 75% requiring RT, 25% requiring chemotherapy). Additional therapy is determined by the participant's care team as part of their standard of care treatment, so not all patients will receive additional radiation or chemotherapy.

    Measured: Within 4 months of primary tumor removal surgery

  4. Phase II: Pathologic response of primary tumor and nodal disease

    This looks at how strongly the main tumor and the affected lymph nodes respond to treatment. Pathologic response rates will be determined by comparing pre- and post- surgery tumor tissue samples for patients who have enough pre-op tissue to analyze from pathology.

    Measured: Immediately after primary tumor removal surgery

  5. Phase II: Assessment of Patient Reported quality of life

    Patients will be asked to take the M.D. Anderson Head \& Neck Symptom Inventory Questionnaire (MDASI-HN) at multiple timepoints throughout the study. The MDASI Head and Neck (MDASI-HN) questionnaire is scored by averaging patient-rated items on a 0-10 scale covering 13 core symptoms, 9 head/neck-specific symptoms, and 6 interference items. Higher scores indicate greater symptom severity and worse interference with daily life.

    Measured: From enrollment to 24 Month Follow-Up Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start31 Jan 2027 (estimated)
  3. Primary completion31 May 2030 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07578467
Sponsor's protocol ID
15325
Status last verified
Oct 2026
First submitted
13 Apr 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ATRN-119 and Stereotactic Body Radiation Therapy (SBRT) in people with HPV Positive Oropharyngeal Squamous Cell Carcinoma and Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nick Lukens, MD (215-662-6567, RadOncCRU@PennMedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS (time frame: Within 6 weeks after study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07578467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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