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
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
35
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nick Lukens, MD
- 電話番号：215-662-6567
- メール：RadOncCRU@PennMedicine.upenn.edu
研究連絡先のバックアップ
- 名前：Casey Hanna
- 電話番号：215 - 615 - 1611
- メール：casey.hanna@pennmedicine.upenn.edu
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase II: To assess safety of ATR inhibitor ATRN-119 with nodal SBRT prior to surgery
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase II: Relapse-free survival (RFS) at two years
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月31日
一次修了 (推定)
2030年5月31日
研究の完了 (推定)
2030年8月31日
試験登録日
最初に提出
2026年4月13日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月8日
QC基準を満たした最後の更新が送信されました
2026年7月7日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。