콘텐츠로 이동

국소 진행성 췌장암 환자에서 정위체부방사선치료(SBRT)와 병용하는 XER-001(비십이지장 투여 아미포스틴)의 안전성 및 유효성 평가를 위한 1/2상 임상시험

A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer.

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목 내용
등록번호 NCT07157033
상태 모집 중
단계 1상/2상
시험 약물/중재 XER-001
대상 질환 Locally Advanced Pancreatic Adenocarcinoma, Locally Advanced Pancreas Cancer, Locally Advanced Pancreatic Ductal Adenocarcinoma
스폰서 Xerient Pharma
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 36
시작 / 1차 완료 예정 2026-01-01 / 2029-07-31
국내 실시기관 없음
실시 국가 1개국, 기관 5곳 (United States)
결과 게시 아니오
최근 갱신 2026-08-17

문의처 (등록된 중앙 연락처)

  • Robbin Frnka 2142055746 rfrnka@accelsobio.com
  • Jeanne Jones jjones@accelsobio.com

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요

이 연구는 국소 진행성 췌장암(LAPC) 환자를 대상으로 신약 XER-001과 정위체부방사선치료(SBRT)를 병용하여 안전성, 내약성, 유효성을 평가하고 향후 연구를 위한 최적 용량을 찾기 위해 진행됩니다. 1상에서는 XER-001의 비십이지장 투여에 따른 안전성과 약동학(PK)을 평가합니다. 2a상에서는 십이지장 방사선 용량 제한을 점진적으로 완화하면서 병용 요법의 안전성과 유효성을 평가합니다. 목표 인원은 36명입니다.

  • 목표 인원은 36명입니다.
  • 중재 치료로 XER-001과 정위체부방사선치료(SBRT)를 사용합니다.
  • 초록에 생존기간, 반응률, 위험비 등의 수치는 명시되지 않음.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 세포학적 또는 생검으로 확증된 췌장 선암종 - 췌장담도 전문 외과의와 다학제 팀 검토를 통해 SBRT 치료가 적합하다고 판단된 국소 진행성 및/또는 기술적으로 절제 불가능한 질환, 혹은 해부학적으로 잠재적 절제 가능하나 합병증 등으로 수술 대상이 아니거나 수술을 거부하고 SBRT를 선호하는 경우 - 장 접촉은 허용되나 내시경 또는 조영증강 영상에서 장 침윤이나 침거는 허용되지 않음 - 유도 전신 치료 전후로 원격 전이 없음 - FOLFIRNOX, 젬시타빈/아브락산 등 의학적으로 적절한 1차 전신 치료 완료 - SBRT 관련 절차(숨참기 기법 등)를 이해하고 따를 수 있는 환자 - 연령 18세 이상 - 동부종양임상연구협력그룹(ECOG) 활동도 0, 2점 - 적절한 혈액학적 기능(절대중성구수 1500/mm3 이상, 혈색소 8.0 g/dL 이상, 혈소판 75,000/mm3 이상) - 간 질환이나 간 기능 장애가 없고 기준치를 만족하는 간 기능 - 기저 혈청 칼슘 8.4 mg/dL 이상 - 임상적으로 유의미한 12유도 심전도(ECG) 이상 소견이 없는 경우 - 프로토콜에 따른 평가 일정과 절차를 준수할 의지와 능력이 있는 경우 - 사전 서면 동의서 제공 - 임신 가능성이 있는 여성 및 가임기 파트너가 있는 남성의 경우 규정된 기간 동안 적절한 피임법 준수 동의 제외 기준: - 상복부 방사선 치료 이력이 SBRT 조사야와 겹치는 경우 - 방사성의약품 치료 이력 - 췌장 종양의 이전 수술적 절제 이력 - 등록 후 30일 이내에 조절되지 않거나 활성화된 위 또는 십이지장 궤양 질환 - 내시경 평가 시 장/위/십이지장 내강으로 종양이 눈에 띄게 침입한 경우 - 탈모를 제외한 항암화학요법으로 인한 잔여 또는 진행 중인 3등급 이상의 비혈액학적 독성 - 다른 중재적 임상시험에 동시 참여 중이거나 다른 시험용 의약품 사용

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  1. Cytologic or biopsy confirmed adenocarcinoma of the pancreas

  2. Disease deemed amenable to definitive treatment with SBRT by being:

  3. Locally-advanced and/or technically unresectable, as determined by a specialist pancreaticobiliary surgeon and as part of a multidisciplinary team review including of multiphase cross-sectional imaging, demonstrating: i. Greater than 180-degree tumor involvement of the superior mesenteric artery (SMA) ii. Greater than 180-degree tumor involvement of the celiac axis including major branches of the celiac axis that would render the tumor unresectable (e.g. common hepatic artery) iii. Tumor involvement of the first branch of the SMA that is not surgically reconstructible iv. Long segment involvement of the superior mesenteric vein/portal vein/hepatic artery that is not amenable to surgical reconstructible.

  4. Potentially resectable anatomically but deemed not a surgical candidate after multidisciplinary review (such as unresectable due to comorbid conditions that render.

    the risks of surgery prohibitive)

  5. Potentially resectable but the patient elects to refuse surgery and prefers to pursue SBRT, and disease is deemed eligible for SBRT

  6. Primary tumor involvement abutment of the bowel is allowed, however bowel infiltration or invasion (identified endoscopically or by contrast enhanced imaging) is not allowed.
  7. No distant metastatic disease either prior to or following induction systemic therapy
  8. Completion of medically indicated first line systemic therapy, which may include but is not limited to regimens such as FOLFIRNOX, gemcitabine/abraxane, and similar regimens
  9. Patients must be able to understand and comply with any treatment related procedures for SBRT. including breath-hold techniques or tolerance of compression belt, or other motion management strategies for SBRT delivery.
  10. Age 18 years or older
  11. Eastern Cooperative Group (ECOG) performance status 0, 1, or 2

  12. Adequate hematologic function as indicated by:

  13. Absolute neutrophil counts >/= 1500/mm3

  14. Hemaglobin >/= 8.0 g/dL
  15. Plor current use of hepato atelet count >/= 75,000/mm3

  16. No known liver disease or hepatic impairment, as well as no recent or current use of hepatotoxic drugs or substances that could compromise liver function unless a washout period has been completed. Adequate liver function as indicated by:

    1. Total bilirubin \</= 1.5x upper limits of normal (per institutional laboratory reference standard)
    2. Aspartate aminotransferase (AST) and alanine aminotranferase (ALT) \</= 2.5 upper limits of normal (per institutional reference standard)

  17. Baseline serum calcium level >/= 8.4 mg/dL

  18. No clinically significant history or presence of safety 12-lead ECG findings as judged by the investigator at screening and check-in(s), including each criterion as listed below:

    1. Normal sinus rhythm (heart rate between 40 and 100 bpm)
    2. QTcF interval \</= 470 msec
    3. QRS interval \</= 110 msec
    4. and PRS interval \</= 220 msec Repeat measurements may be performed at the discretion of the investigator or designee

  19. An understanding, ability, and willingness to fully comply with the protocol-defined schedule of assessments, procedures, and restrictions

  20. Must provide written informed consent prior to the initiation of any protocol specific procedures

  21. The effects of XER-001 on the developing human fetus are unknown. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least six months following the last (fifth) day of radiotherapy on this study. Exceptions to this inclusion criterion are available to women who meet any of the following criteria:

    • Postmenopausal (no menses in greater than or equal to 12 consecutive months or validated by follicle stimulating hormone [FSH] levels.
    • History of hysterectomy or bilateral salpingo-oophorectomy
    • Ovarian failure (FSH and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
    • History of bilateral tubal ligation or another surgical sterilization procedure

  22. Approved methods of birth control are as follows: hormonal contraception (I.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms with spermacide. Not engaging in sexual activity through six months following the last (fifth) day of radiotherapy on this study is an acceptable practice; however periodic abstinence, the rhytm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

For male participants on this trial, contraception is required as above dusing the study and for at least three months following the last (fifth) day of radiotherapy on this study if the have partners who can become pregnant (woman of child-bearing potential). Similarly, male participants on this trial should not donate sperm during the study and for at lease three months following the last (fifth) day of radiotherapy on this study.

Exclusion Criteria:

  1. Prior radiotherapy to the upper abdomen with overlap of. the anticipated SBRT field
  2. Prior radiopharmaceutical therapy
  3. Prior surgical resection of the pancreatic tumor
  4. Uncontrolled or active gastric or duodenal ulcer disease within 30 days of enrollment
  5. Visable invasion of tumor into the bowel/stomach.duodenal lumen on endoscopic evaluation
  6. Residual or ongoing grade 3+ non-hemotological toxicity from chemotherapy other than alopecia
  7. Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of study consent. Note that participation in non-interventional clinical trials (e.g. quality of life [QOL], imaging, etc) is not exclusionary
  8. Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia
  9. Patients with history of myocardial infarction or unstable angina within 6 months prior to study enrollment
  10. Patients with history of symptomatic or (CTCAE-defined) grade 3+ hypocalcemia
  11. Patients with history of hypoparathyroidism
  12. Patients with history of hypertension where medical providers deem that interruption of antihypertensive regimen for one week is deemed unsafe.
  13. Patients with systolic blood pressure (BP) \< 100 or diastolic BP \< 65 at screening or baseline

  14. History or presence of a disease, such as hepatic impairment or renal insufficiency, that could affect the absorption, distribution, metabolism, or elimination of the investigational product, tolerance to radiotherapy, or could affect clinical or laboratory assessments.

    Patients with an estimated glomerular filtration rate of less than 30 mL per minute are excluded from the trial. Patients with total bilirubin greater than 2.5 mg/dL are excluded from the trial unless patient has history of Gilbert's syndrome. In case of suspected or confirmed Gilbert's syndrome, bilirubin will be fractionated, and patients with direct bilirubin greater than 1.5 mg/dL will be excluded from the trial.

  15. History of cardiac-related condition, which may include, but is not limited to, torsades de pointes, ventricular fibrillation, or ventricular tachycardia

  16. Presence or family history (parents and siblings) of congenital lqt syndrome or any premature history of myocardial infarction considered clinically significant by the investigator or designee
  17. History or presence of palpitations, unexplained syncope, shortness of breath or any other symptoms that may relate to cardiac arrhythmias
  18. Any ECG evidence of physiological variants predisposing to electrical instability (eg. frequent pre-ventricular systolic beats)
  19. Medical disorder that may require treatment during the study or make the subject unlikely to complete the study.
  20. Inability to fast for 3 hours prior to study drug administration
  21. Known history of active hepatitis B/C or active human immunodeficiency virus (HIV) not on highly-active anti-retroviral therapy for a minimum of 30 days
  22. Donation or loss of more than 500 ml of whole blood within 30 days prior to screening
  23. Difficulty with venous access or unstable or unwilling to undergo catheter insertion
  24. Female subjects who are currently pregnant (have a positive pregnancy test), are lactating, or planning to breastfeed. Pregnant or breastfeeding women are excluded from this study because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with amifostine, breastfeeding should be discontinued if the mother is treated with amifostine
  25. An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  26. A subject who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

댓글 기능은 아직 설정 전입니다 (관리자: docs/SETUP.md의 giscus 항목 참고). 의견은 GitHub Discussions에 남겨 주세요.