Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs
2026년 7월 7일 업데이트: 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
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
35
단계
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Nick Lukens, MD
- 전화번호: 215-662-6567
- 이메일: RadOncCRU@PennMedicine.upenn.edu
연구 연락처 백업
- 이름: Casey Hanna
- 전화번호: 215 - 615 - 1611
- 이메일: casey.hanna@pennmedicine.upenn.edu
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase II: To assess safety of ATR inhibitor ATRN-119 with nodal SBRT prior to surgery
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Phase II: Relapse-free survival (RFS) at two years
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 8월 31일
기본 완료 (추정된)
기본 완료
2030년 5월 31일
연구 완료 (추정된)
연구 완료
2030년 8월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 4월 13일
QC 기준을 충족하는 최초 제출
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2026년 5월 5일
처음 게시됨 (실제)
처음 게시됨
2026년 5월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 8일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 15325
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