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

NCT07578467 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-11

No results posted yet for this study

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

Conditions

  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma
  • HPV (Human Papillomavirus)-Associated Carcinoma
  • HPV Associated Cancers
  • Oropharyngeal HPV Squamous Cell Carcinoma

Interventions

DRUG

ATRN-119

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

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

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

Sponsors & Collaborators

  • Aprea Therapeutics

    collaborator INDUSTRY

  • John Lukens

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-05-31
Completion
2030-05-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578467 on ClinicalTrials.gov