[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639699":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":21,"responsibleParty":37,"collaborators":39,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":21,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":21,"enrollmentInfo":52,"targetDuration":21,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":21,"overallStatus":66,"whyStopped":21,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":21},{"fullName":5,"class":6},"Abramson Cancer Center at Penn Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","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.",[13,14],"Drug: ATRN-119","Radiation: Stereotactic Body Radiation Therapy (SBRT)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","ATRN-119","ATRN-119 at 800 mg QD (every day) for 10 days",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"RADIATION","Stereotactic Body Radiation Therapy (SBRT)","10 Gy administered to nodal disease (neck) only on day 3 of ATRN-119 dosing",[9],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Nick Lukens, MD","CONTACT","215-662-6567","RadOncCRU@PennMedicine.upenn.edu",{"name":34,"role":30,"phone":35,"phoneExt":21,"email":36},"Casey Hanna","215 - 615 - 1611","casey.hanna@pennmedicine.upenn.edu",{"type":38,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[40],{"name":41,"class":42},"Aprea Therapeutics","INDUSTRY","100639699","phase-1-combining-neo-adjuvant-atr-inhibition-with-nodal-sbrt-for-early-stage-resectable-hpv-opsccs-100639699",false,"NCT07578467","Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs","A Phase Ib\u002FII Study Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs","Inclusion Criteria:\n\n* Age ≥ 18\n* Patients that have been diagnosed with HPV-positive throat cancer (OPSCC) at an early stage (stage I or II), confirmed by a biopsy.\n* Patients' blood calcium level is within a safe range\n* Patients' blood, kidney, and liver health are strong enough, shown through specific medical test results\n* If a participant is female, she must not be pregnant or breastfeeding.\n* 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.\n\nExclusion Criteria:\n\n* Patients with late-stage tumors (Stage III or IV)\n* If the cancer has already spread to distant parts of the body (M1) when first diagnosed\n* Prior advanced head and neck cancer requiring radiation or major surgery\n* Patients whose original tumor site cannot be identified\n* Patients that have a known additional malignancy that is progressing or requires active treatment\n* 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).\n* Patients taking medications that strongly affect how the body processes certain drugs (CYP enzymes) at the same time as the study treatment.\n* Patients with active infections and\u002For receiving systemic antibiotics or anti-viral medications.\n* 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\n* Current or past diagnosis of leukemia within the past 5 years.\n* Patients with a history of non-malignant gastrointestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.\n* Patient has uncontrolled hypertension at time of enrollment.\n* Patients who recently had serious kidney problems or kidney disease.\n* 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\n* Medical illness that, in the opinion of the Investigator, may impact the safety of the patient\n* 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.\n* Known hypersensitivity to ATRN-119 or its ingredients\n* Patients with serious liver disease or liver problems that could affect how the body processes the study drug\n* Patients who are fairly limited in daily activities (ECOG score of 2 or higher)\n* Patients with serious other health problems that the doctor thinks could prevent them from completing the study\n* Pregnancy or lactation\n* Inability to provide informed consent","ALL","18 Years",{"count":53,"type":54},35,"ESTIMATED","INTERVENTIONAL",[57,58],"PHASE1","PHASE2","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.\n\nThe 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.\n\nParticipants will:\n\n* Take 800mg of ATRN-119 every day for 10 days\n* Receive 1 treatment (called a \"fraction\") of SBRT to the neck on day 3 of ATRN-119 dosing.\n* Keep a short diary to track ATRN-119 dosing. The diary will be provided by study team\n* 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)\n* Receive additional safety checkups and tests by researchers during routine visits with their cancer doctor for 2 years after study treatment",[61,62,63,64,65],"HPV Positive Oropharyngeal Squamous Cell Carcinoma","Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","HPV Associated Cancers","Oropharyngeal HPV Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-30",{"date":69,"type":70},"2026-07-02","ACTUAL",{"date":72,"type":54},"2026-05-31",{"date":74,"type":54},"2030-05-31",{"name":5,"class":6}]