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

Официальное название

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

Обзор

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

Вмешательства

• Препарат ATRN-119
  ATRN-119 at 800 mg QD (every day) for 10 days
• Лучевая терапия Stereotactic Body Radiation Therapy (SBRT)
  10 Gy administered to nodal disease (neck) only on day 3 of ATRN-119 dosing

Первичные конечные точки

• Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS [Срок оценки: Within 6 weeks after study treatment]
• Phase II: Major pathologic response (MPR) rate of radiated nodal disease [Срок оценки: Immediately after standard of care primary tumor removal surgery]

Вторичные конечные точки (5)

• Phase II: To assess safety of ATR inhibitor ATRN-119 with nodal SBRT prior to surgery [Срок оценки: From start of study treatment through standard of care 2-year Follow-Up visit]
• Phase II: Radiographic response rates [Срок оценки: 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 [Срок оценки: Within 4 months of primary tumor removal surgery]
• Phase II: Pathologic response of primary tumor and nodal disease [Срок оценки: Immediately after primary tumor removal surgery]
• Phase II: Assessment of Patient Reported quality of life [Срок оценки: From enrollment to 24 Month Follow-Up Visit]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07578467 · 15325

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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