새로 진단된 전이성 췌장암 환자에서 표준 항암화학요법과 결합한 VCN-01의 빈번한 투여 주기에 대한 연구¶

A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic 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	NCT07701486
상태	모집 중
단계	1상/2상
시험 약물/중재	VCN-01 oncolytic adenovirus (zabilugene almadenorepvec), Nab-paclitaxel + Gemcitabine
대상 질환	Pancreas Cancer, Metastatic, Pancreas Cancer, Stage IV, Ductal Adenocarcinoma of the Pancreas
스폰서	Theriva Biologics SL
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	6
시작 / 1차 완료 예정	2026-08-03 / 2027-08-01
국내 실시기관	없음
실시 국가	1개국, 기관 1곳 (Spain)
결과 게시	아니오
최근 갱신	2026-07-27

문의처 (등록된 중앙 연락처)¶

Manel Cascalló CEO, PhD +93936899365 mcascallo@therivabio.com

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

시험 개요¶

이 임상시험은 새로 전이성 췌장암(metastatic pancreatic cancer)을 진단받고 치료받지 않은 성인 환자를 대상으로 합니다. 종양용해성 아데노바이러스(oncolytic adenovirus)인 VCN-01을 표준 항암화학요법인 gemcitabine(젬시타빈) 및 nab-paclitaxel(납-패클리탁셀)과 함께 투여하는 새로운 요법의 안전성과 내성을 평가합니다. 환자들은 56일마다 한 번씩 총 3회의 VCN-01 투여를 받으며, 각 투여 후 표준 화학요법이 이어집니다. 목표 인원은 6명이며, 초록에 치료 효과나 생존기간 등의 결과는 명시되지 않았습니다.

대상 질환: 새로 진단된 4기 전이성 췌장 췌관 선암종(pancreatic ductal adenocarcinoma, PDAC)
시험 중재: VCN-01 oncolytic adenovirus와 gemcitabine, nab-paclitaxel 병용
목표 인원: 6명
효과 및 생존기간 수치: 초록에 명시되지 않음

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준: - 만 18세 이상의 남녀 환자 - 조직학적 또는 세포학적으로 확진된 전이성(4기) 췌장 선암종 환자로서 췌장암 치료를 받은 적이 없는 자 - 전이성 췌장암 진단 후 6주 이내에 첫 번째 VCN-01 투여를 받을 수 있는 자 - RECIST 1.1 기준에 따라 영상 평가가 가능한 측정 가능한 종양 병소가 최소 1개 이상인 자 - 등록 당시 ECOG 신체 상태 평가(performance status)가 0 또는 1인 자 - 적절한 장기 기능(혈액학적, 간, 신장)을 충족하는 자. 제외 기준: - 지리적, 정신적, 사회적 이유로 임상시험 절차를 완료할 수 없는 자 - 전이성 췌장암에 대해 수술, 방사선치료, 항암화학요법 또는 임상시험용 치료를 이전에 받은 적이 있는 자(통증 완화 목적의 방사선치료 및 담도 스텐트 삽입은 허용됨) - 스크리닝 기간 동안 임상적으로 수용할 수 없는 악화를 시사하는 증상이나 징후가 있는 자 - 활성 감염, 기타 심각한 질환 또는 자가면역 질환이 있는 자 - 만성 간질환, 동시 악성 혈액 질환 또는 고형암 병력이 있는 자 - 치료받지 않은 뇌전이 및/또는 연막 카르시노마토시스가 있는 자 - 이전 폐렴이나 간질성 폐질환 병력이 있는 자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

Written informed consent obtained prior to initiating any trial-specific procedures or assessments.
Male or female patients aged 18 years or over.
Patients with histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic (stage IV) at diagnosis and who have not received any treatment for their pancreatic cancer.
Patients must be able to receive their first dose of VCN-01 ≤6 weeks after their metastatic pancreatic cancer diagnosis.
Patients must have at least one measurable tumor lesion that can be imaged for assessments according to RECIST 1.1.
ECOG performance status of 0 or 1 at enrollment.
Must be willing to comply with the trial intervention, including prophylactic medications, and procedures.
Adequate baseline organ function (hematologic, liver, renal) within the 7 days prior to enrollment:

Hematology:

Leukocytes ≥3.0x103 mcL
Absolute neutrophil count ≥1.5x10⁹/L
Hemoglobin ≥9 g/dL
Platelets ≥100x10⁹/L

Coagulation:

Prothrombin time or international normalized ratio ≤1x upper limit of normal (ULN)
Activated partial thromboplastin time ≤1.2xULN

Hepatic:

Total bilirubin ≤1.5xULN
ALT and AST ≤2.5xULN (\<5xULN is acceptable if liver metastases are present)

Renal:

Serum creatinine ≤1.5xULN; or,
If serum creatinine >1.5xULN, an estimated creatinine clearance >50 mL/min using the Cockcroft and Gault formula

Nutritional:

• Serum Albumin ≥30 g/L

- Adequate left ventricular ejection fraction (LVEF) ≥ 50% measured by ECHO or MUGA and QT interval corrected by Fridericia (QTcF) assessment ≤ 450 ms for men or ≤ 470 ms for women.

Exclusion Criteria:

Unwillingness to complete the trial procedures for geographic, psychiatric, or social reasons.
Patient has previously received treatment for their metastatic pancreatic cancer with surgery, radiotherapy, chemotherapy or investigational therapy; except that:
Palliative radiotherapy for pain is permitted;
Placement of a biliary stent/tube is permitted.
Patients who, in the opinion of the investigator, have symptoms or signs suggesting clinically unacceptable deterioration during the Screening Period.
Active infection or other serious illness or autoimmune disease at the moment of enrollment. Active infection includes:

• Tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice. * Patients with past or resolved TB are eligible to participate.

• Hepatitis B Virus (HBV; positive HBV surface antigen [HBsAg] result). * HBV carriers (patients positive for HBsAg without an active infection) are not eligible to participate; * Patients requiring antiviral medicines for HBV prophylaxis or treatment are not eligible to participate; * Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible to participate provided that blood HBV DNA is negative at enrollment.

• Hepatitis C Virus (HCV; positive HCV Ribonucleic acid [RNA]). * Patients requiring antiviral medicines for HCV prophylaxis or treatment are not eligible to participate; * Patients positive for HCV antibody are eligible to participate (only if polymerase chain reaction is negative for HCV RNA).

Human immunodeficiency virus (positive HIV 1/2 antibodies)

Active infection or other serious illness or autoimmune disease at the moment of enrollment. Active infection includes:

Tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice.

- Patients with past or resolved TB are eligible to participate. * Hepatitis B Virus (HBV; positive HBV surface antigen [HBsAg] result).

HBV carriers (patients positive for HBsAg without an active infection) are not eligible to participate;
Patients requiring antiviral medicines for HBV prophylaxis or treatment are not eligible to participate;
Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible to participate provided that blood HBV DNA is negative at enrollment.
Hepatitis C Virus (HCV; positive HCV Ribonucleic acid [RNA]).
Patients requiring antiviral medicines for HCV prophylaxis or treatment are not eligible to participate;
Patients positive for HCV antibody are eligible to participate (only if polymerase chain reaction is negative for HCV RNA).
Human immunodeficiency virus (positive HIV 1/2 antibodies)
Known chronic liver disease (e.g. liver cirrhosis, liver fibrosis, chronic hepatitis); except that:
Patients with fatty liver disease are eligible to participate if their liver transaminases meet inclusion criterion 8.
Concurrent malignant hematologic or solid disease; except that:
Patients with a prior history of cancer are eligible to participate if they are in complete remission from their prior cancer for at least 3 years.
Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency.
Patients with untreated brain metastases and/or leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage; except that:
Patients with brain metastases with stable symptoms are eligible to participate.
Patients with previous pneumonitis or interstitial lung disease.
Patients with pre-existing sensory neuropathy >G1
Clinical evidence of deep vein thrombosis, pulmonary embolism or arterial thromboembolic event during the Screening Period.
Patients with superficial vein thrombosis are eligible to participate.
Patients with uncontrolled coagulopathy.
Any other condition, disease, metabolic dysfunction (e.g., uncontrolled diabetes mellitus), active or uncontrolled infection/inflammation, physical examination finding, mental state or clinical laboratory finding that would contraindicate participation in the clinical trial due to concerns over safety or potential non-compliance with clinical trial procedures.
A female patient, who is pregnant or lactating.
Female patients of reproductive potential must agree to use a highly effective method of birth control. Male patients must agree to use condoms.
Treatment with live attenuated vaccines in the last 3 weeks before the administration of the IMP.
Treatment with an adenovirus type-5 (Ad5)-based COVID-vaccine in the last 12 weeks before the administration of the IMP.
Treatment with another investigational agent within five of that investigational agent's half-lives prior to the administration of the IMP.
Chronic immunosuppressive therapy; except that:
Inhaled corticosteroids are permitted;
Oral or IV corticosteroids with a dose lower than 10 mg prednisone or equivalent/day are permitted;
Dexamethasone up to a maximum dose of 1 mg/day is permitted.
Known allergy or hypersensitivity to any of the trial-specific interventions or any of their excipients.
Subjects, for whom first line treatment options other than the combination nab-paclitaxel/gemcitabine are recommended by the investigator.

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

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