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전이성 췌장암 환자를 위한 EDV 나노셀 치료제(E-EDV-D682/GC)와 젬시타빈 및 냅-파클리탁셀 병용 투여 임상시험

A Clinical Trial to Evaluate EDV Nanocell Therapy With Gemcitabine and Nab-paclitaxel in 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 NCT07049055
상태 모집 중
단계 1상/2상
시험 약물/중재 E-EDV-D682, EDV-GC, Gemcitabine, Nab paclitaxel.
대상 질환 Pancreatic Cancer, Metastatic, PDAC - Pancreatic Ductal Adenocarcinoma
스폰서 Engeneic Pty Limited
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 144
시작 / 1차 완료 예정 2026-01-12 / 2028-09
국내 실시기관 없음
실시 국가 1개국, 기관 4곳 (United States)
결과 게시 아니오
최근 갱신 2026-02-27

시험 개요

이 연구는 1차 치료(5-FU 기반 병용요법) 후 진행된 전이성 췌장소관암(PDAC) 환자를 대상으로 합니다. 실험 치료인 E-EDV-D682/GC는 표피성장인자수용체(EGFR)를 표적으로 하는 EDV 나노셀에 항암제를 담아 종양 세포에 직접 전달하고 면역계를 활성화하는 방식입니다. 연구는 1상 안전성 평가 코호트와 2상 무작위 배정(ARM A: 시험군 92명, ARM B: 대조군 46명) 확장 코호트로 진행됩니다. 총 목표 인원은 144명이며, 전체 생존기간(OS)과 안전성 및 내인성을 평가합니다.

  • 목표 인원은 총 144명이며, ARM A(시험군) 92명과 ARM B(대조군) 46명으로 2:1 무작위 배정됩니다.
  • 시험군은 E-EDV-D682/GC와 gemcitabine(젬시타빈), nab-paclitaxel(냅-파클리탁셀)을 병용 투여받습니다.
  • 대조군은 gemcitabine, nab-paclitaxel과 위약을 투여받습니다.
  • 1차 치료로 FOLFIRINOX 또는 NALIRIFOX 치료 후 질병이 진행된 전이성 췌장관선암(PDAC) 환자를 대상으로 합니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 전이성 췌장 선암(pancreas adenocarcinoma)의 조직학적 또는 병리학적 확진 - 18세 이상의 남성 또는 여성 - ECOG 수행 능력 점수 0-1 - 연구자의 판단에 따른 기대 여명 3개월 이상 - iRECIST 기준에 따른 측정 가능한 병변 존재 - 종양이 EGFR을 발현할 것 - FOLFIRINOX 또는 NALIRIFOX 1차 치료 중 또는 치료 종료 후 3개월(+/- 15일) 이내에 문서화된 질병 진행 확인 - 전이성 PDAC에 대해 선행 전신 치료 라인이 1회 이하일 것 - 알부민 수치 > 3.0 g/dl - 적절한 조혈, 신장, 간, 심장 기능 보유

제외 기준: - 현재 다른 임상시험용 약물을 투여받고 있는 경우 - 최대 지지요법으로 조절되지 않는 이전 항암 치료로 인한 미해결(≥ 1단계) 비혈액학적 이상 반응 - 배액이 필요한 유의미한 심낭 삼출, 흉수, 복수가 있는 경우 - 렙토수막 또는 뇌/중추신경계 전이 병력 - 다른 악성 종양에 대한 진행 중인 치료 - 전립선암 외에 스크리닝 전 2년 이내에 PDAC 외의 악성 종양 병력이 있는 경우 - 조절되지 않는 당뇨병 또는 코르티코스테로이드 사용 금기증 - 조절되지 않는 관상동맥 질환, 울혈성 심부전, 고혈압, 심부 부정맥 병력 - 조절되지 않는 HIV, B형 간염, C형 간염 바이러스 감염 - 임신 중이거나 수유 중인 여성

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  • Histological or pathological confirmation of metastatic pancreas adenocarcinoma. Cytological or histological evidence of metastatic disease is required.
  • Male or Female greater than or equal to 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
  • Life expectancy ≥ 3 months in the opinion of the Investigator.
  • Measurable disease as per iRECIST criteria.
  • Subjects must have tumors that express EGFR.
  • Documented disease progression with first line FOLFIRINOX or NALIRIFOX therapy, during or within 3 months (+/- 15 days) after end of therapy.
  • No more than one line of prior systemic therapy for metastatic PDAC allowed.
  • Albumin level > 3.0 g/dl
  • Adequate hematological function.
  • Adequate renal function.
  • Adequate hepatic function.
  • Adequate cardiac function with LVEF ≥ 50% at baseline.
  • Reproductive criteria as follows:
  • Female subjects who are of non-reproductive potential
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose.
  • Female subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
  • Male subjects must be willing to use highly effective methods of birth control during the period of therapy and for 6 months following the last study drug administration.
  • All study subjects must be willing to ensure that corresponding sexual partners practice these same methods of highly effective birth control for the same duration.
  • The subject (or subject's legally authorized representative) has provided voluntary signed informed consent.
  • According to the investigator's assessment, subject will be able to comply with the study protocol.

Exclusion Criteria:

  • Subjects currently receiving any other investigational agent.
  • Unresolved (≥ Grade 1) non-hematological adverse events from prior anti-cancer therapy that is not controlled on maximal supportive therapy.
  • Significant pericardial effusions, pleural effusions, or ascites that requires intervention. Subjects who require drainage within the last four weeks are ineligible.
  • History of leptomeningeal or brain/CNS metastases.
  • Ongoing treatment for other malignancies (hormone therapy acceptable).
  • Patient may not have a history of malignancy other than PDAC within two years prior to screening except in circumstances where the risk of recurrence, metastasis or death in 5-years is \<10%.
  • Concurrent unstable diabetes mellitus or other contraindications for the use of corticosteroids that requires active titration of insulin.
  • Subject has experienced a history of uncontrolled coronary artery disease, with or without angina pectoris or myocardial infarction, symptomatic congestive heart failure (New York Heart Association > Class II)
  • Uncontrolled hypertension (systolic > 180 mmHg or diastolic > 100 mmHg) within two weeks.
  • Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy within the last four weeks.
  • Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females).
  • Uncontrolled HIV infection. Patients without a prior diagnosis of HIV infection will undergo HIV testing unless not permitted to do so under local regulations. Patients with known HIV who have controlled infection (viral load undetectable and a CD4 count >350 either spontaneously or on a stable antiviral regimen) are permitted.
  • Uncontrolled Hepatitis B virus (HBV) infection (chronic or acute).
  • Uncontrolled Hepatitis C virus (HCV) infection.
  • Uncontrolled arterial or venous thrombosis.
  • Active or uncontrolled severe infection.
  • Uncontrolled hypercalcemia (>2.6mmol/L or >10.3mg/dL) or symptomatic hypercalcemia requiring continued treatment for hypercalcemia.
  • Received the following procedures within 21 days to receiving their first dose (or has not recovered from the toxic effects of such therapy) including:
  • other investigational therapy
  • radiotherapy
  • any major surgery.
  • Prior other therapies or procedures prior to receiving their first dose:
  • QTc interval prolonging medicines should be reviewed and where possible their use should be minimized and alternate medicines that are not QTc interval prolonging, considered as substitutes.
  • Known allergy/hypersensitivity to investigational components or excipients (trehalose, monoclonal antibody infusions, interferon therapy, or ciprofloxacin HCl (or other quinolones).
  • Female who is pregnant or breastfeeding.
  • Subject who cannot comply with protocol scheduled study visits or procedures, to the best of the subject and Investigator's knowledge.
  • Any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
  • History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

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

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