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

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT07578467
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATRN-119 — DRUG
    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 Details

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

Key Dates

First listed
May 11, 2026
Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Patients 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.

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 ]

Central Contacts

Find similar trials

Nationwide
Skin cancer trialsOncology trialsSkin cancer trialsDermatology trials

Related Studies