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

5 maggio 2026 aggiornato da: John Lukens

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.

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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

35

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: ATRN-119
ATRN-119 at 800 mg QD (every day) for 10 days
Radiazione: Stereotactic Body Radiation Therapy (SBRT)
10 Gy administered to nodal disease (neck) only on day 3 of ATRN-119 dosing

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS
Lasso di tempo: Within 6 weeks after study treatment
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.
Within 6 weeks after study treatment
Phase II: Major pathologic response (MPR) rate of radiated nodal disease
Lasso di tempo: Immediately after standard of care primary tumor removal surgery
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.
Immediately after standard of care primary tumor removal surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase II: To assess safety of ATR inhibitor ATRN-119 with nodal SBRT prior to surgery
Lasso di tempo: From start of study treatment through standard of care 2-year Follow-Up visit
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.
From start of study treatment through standard of care 2-year Follow-Up visit
Phase II: Radiographic response rates
Lasso di tempo: 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.
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.
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.
Phase II: Type of adjuvant treatment required
Lasso di tempo: Within 4 months of primary tumor removal surgery
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.
Within 4 months of primary tumor removal surgery
Phase II: Pathologic response of primary tumor and nodal disease
Lasso di tempo: Immediately after primary tumor removal surgery
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.
Immediately after primary tumor removal surgery
Phase II: Assessment of Patient Reported quality of life
Lasso di tempo: From enrollment to 24 Month Follow-Up Visit
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.
From enrollment to 24 Month Follow-Up Visit

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase II: Relapse-free survival (RFS) at two years
Lasso di tempo: From the completion of treatment, either surgery in those not receiving adjuvant therapy, or completion of all adjuvant therapy and will last for 2 years
Participants will be checked over a 2-year period to see if their disease comes back. A "relapse" means the disease returns either in the same place, nearby areas, or elsewhere in the body. Any return of the disease must be confirmed with medical testing (like examining tissue under a microscope).
From the completion of treatment, either surgery in those not receiving adjuvant therapy, or completion of all adjuvant therapy and will last for 2 years
Phase II: Measures of activation of anti-tumor immunity in primary tumor and blood
Lasso di tempo: From enrollment to date of primary tumor removal surgery
Researchers will study samples taken from each patient's main tumor and blood both before and after treatment given prior to the main therapy. This helps them see how the treatment affects the cancer and the body.
From enrollment to date of primary tumor removal surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

John Lukens

Collaboratori

Aprea Therapeutics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

31 maggio 2026

Completamento primario (Stimato)

31 maggio 2030

Completamento dello studio (Stimato)

31 maggio 2030

Date di iscrizione allo studio

Primo inviato

13 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 859861

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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