NCT07578467尚未招募1 期
A Phase Ib/II Study Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 35
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-
- •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
研究组 & 干预措施
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.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
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.
干预措施: ATRN-119 (Drug)
研究者
John Lukens
MD
University of Pennsylvania
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