Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs
2026年7月7日 更新者：Abramson Cancer Center at Penn Medicine
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
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
35
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Nick Lukens, MD
- 电话号码：215-662-6567
- 邮箱：RadOncCRU@PennMedicine.upenn.edu
研究联系人备份
- 姓名：Casey Hanna
- 电话号码：215 - 615 - 1611
- 邮箱：casey.hanna@pennmedicine.upenn.edu
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
ATRN-119 at 800 mg QD (every day) for 10 days
10 Gy administered to nodal disease (neck) only on day 3 of ATRN-119 dosing
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Phase II: To assess safety of ATR inhibitor ATRN-119 with nodal SBRT prior to surgery
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Phase II: Relapse-free survival (RFS) at two years
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月31日
初级完成 (估计的)
2030年5月31日
研究完成 (估计的)
2030年8月31日
研究注册日期
首次提交
2026年4月13日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年7月8日
上次提交的符合 QC 标准的更新
2026年7月7日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.