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육종 또는 위장관암 환자 대상 64Cu-LNTH-1363S 임상시험

64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer

안내

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항목 내용
등록번호 NCT06298916
상태 모집 중
단계 1상/2상
시험 약물/중재 64Cu-LNTH-1363S
대상 질환 Metastatic Sarcoma, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Colorectal Cancer, Sarcoma
스폰서 Lantheus Medical Imaging
연령·성별 15 Years ~ 제한 없음 · ALL
목표 인원 26
시작 / 1차 완료 예정 2025-08 / 2025-11
국내 실시기관 없음
실시 국가 1개국, 기관 5곳 (United States)
결과 게시 아니오
최근 갱신 2025-08-12

문의처 (등록된 중앙 연락처)

  • Eryn Bagley 978-671-8886 clinicaltrials@lantheus.com

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

시험 개요

이 임상시험은 고형암(전이성 육종 및 췌장암 등 위장관암 포함) 환자를 대상으로 신규 방사성 의약품인 64Cu-LNTH-1363S의 안전성, 내인성, 선량 측정, 최적의 영상 용량 및 최적의 촬영 시간 창을 평가하기 위한 다기관, 공개, 전향적 제1/2a상 연구입니다. 파트 1에서는 전이성 육종 환자 6명을 대상으로 약물의 체내 분포와 선량 등을 평가합니다. 파트 2에서는 수술 예정인 비전이성 고형암 환자 20명을 대상으로 약물 흡수와 섬유아세포 활성단백(FAP) 발현 간의 상관관계를 평가합니다. 총 목표 인원은 26명이며 국내 기관은 없습니다.

  • 목표 인원은 총 26명이며 국내 임상 기관은 없습니다.
  • 파트 1은 전이성 육종 환자 6명을 대상으로 안전성과 최적 용량 등을 평가합니다.
  • 파트 2는 수술 예정인 위장관암 및 육종 환자 20명을 대상으로 FAP 발현과의 상관관계를 평가합니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 파트 1: 15세 이상(15~18세 미만은 체중 55 kg 이상), FAP 발현이 의심되는 전이성 육종 진단 확인, 조직 생검 조직 제공 가능, 신기능 크레아티닌 청소율 60 mL/min 이상, 가임기 여성의 임신테스트 음성 및 피임 동의 - 파트 2: 15세 이상(15~18세 미만은 체중 55 kg 이상), 육종 또는 췌장암을 포함한 위장관암 진단 확인, 60일 이내 수술 예정, 수술 후 조직 제공 가능, 신기능 크레아티닌 청소율 60 mL/min 이상, 가임기 여성의 임신테스트 음성 및 피임 동의 제외 기준: - 공통: 프로토콜 절차 준수 불가능, 임신 또는 수유 중, 연구용 의약품 투여 전 14일 이내 전신 항암 치료를 받은 경우, 다른 임상시험 참여 중, 6개월 이내 다른 FAPi 영상 검사를 받았거나 받을 예정인 경우, QT/QTc 간격 연장 병력이 있거나 관련 약물을 복용 중인 경우 - 파트 2 추가: 전이성 또는 진행성 수술 불가 질환 환자, 투여 전 14일 이내 선행 항암 치료를 받은 경우

선정/제외 기준 원문 (영어)

Inclusion Criteria: Part 1

Patients are eligible to be included in the study only if all of the following criteria apply:

  1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \<18 years must weigh at least 55 kg.
  2. Patients with suspected FAP-expressing metastatic sarcoma.
  3. Patients must have histological, pathological, and/or cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).
  4. Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.
  5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
  6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.
  7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.

Inclusion Criteria: Part 2

  1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \<18 years must weigh at least 55 kg.
  2. Patients must have histological, pathological, and/or cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer.
  3. Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging).
  4. Patients must be willing to consent to provide sufficient and adequate tumor tissue samples (formalin fixed, paraffin embedded sample), from their planned surgery after participating in study imaging.
  5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
  6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.
  7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.

Exclusion Criteria: Part 1

Patients are excluded from the study if any of the following criteria apply:

  1. Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.
  2. Known pregnancy or breastfeeding.
  3. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
  4. Patients participating in another clinical trial at the time of screening for this study.
  5. Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.
  6. Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.
  7. History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, > 450 milliseconds) or taking medication known to cause QT/QTc prolongation.
  8. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).

Exclusion Criteria: Part 2

  1. Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration.
  2. Evidence of metastatic or advanced, inoperable disease.
  3. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.
  4. Known pregnancy or breastfeeding.
  5. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
  6. Patients participating in another clinical trial at the time of screening for this study.
  7. Has undergone or plans to undergo PET or SPECT imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.
  8. History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, > 450 milliseconds) or taking drugs known to cause QT/QTc prolongation.
  9. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome

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

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