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진행성 및 절제 불가능 또는 전이성 췌장암 환자에서 OT-101과 mFOLFIRINOX 병용 요법에 대한 임상시험

A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or 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 NCT06079346
상태 모집 중
단계 2상/3상
시험 약물/중재 OT-101, mFOLFIRINOX
대상 질환 Pancreatic Ductal Adenocarcinoma
스폰서 Oncotelic Inc.
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 455
시작 / 1차 완료 예정 2024-05-01 / 2026-06-01
국내 실시기관 없음
실시 국가 1개국, 기관 2곳 (United States)
결과 게시 아니오
최근 갱신 2024-08-13

문의처 (등록된 중앙 연락처)

  • Cynthia Lee, PhD (650) 635-7024 clee@oncotelic.com

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

시험 개요

본 임상시험은 진행성 및 절제 불가능 또는 전이성 췌장암 환자를 대상으로 OT-101과 mFOLFIRINOX(folinic acid, 5-FU, irinotecan, oxaliplatin) 병용 요법의 유효성과 안전성을 mFOLFIRINOX 단독 요법과 비교합니다. 연구의 1차 평가지표는 전체 생존기간(OS)이며, 주요 2차 평가지표는 무진행 생존기간(PFS)과 객관적 반응률(ORR)입니다. 목표 환자 수는 455명이며 현재 환자를 모집 중입니다.

  • 임상시험 단계는 제2b/3상(PHASE2/PHASE3)이며 목표 인원은 455명입니다.
  • 1차 평가지표는 전체 생존기간(OS)이며, 2차 평가지표는 무진행 생존기간(PFS)과 객관적 반응률(ORR)입니다.
  • 치료 중재는 OT-101과 mFOLFIRINOX 병용 요법 대 mFOLFIRINOX 단독 요법입니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 췌장의 원발 투머 또는 비췌장 병변에서 췌관선암(pancreatic ductal adenocarcinoma)으로 조직병리학적 확진을 받은 진행성 및 절제 불가능 또는 전이성 환자 - RECIST v.1.1 기준에 따른 측정 가능한 병변 존재 - 18세 이상의 남성 또는 임신·수유하지 않는 여성 - 동유럽종양학그룹(ECOG) 수행능력 상태(PS) 점수 0-1점 - 적절한 조혈, 간, 신장 기능을 보유하고 기대여명이 3개월 이상인 환자. 제외 기준: - 췌도 신생물, 선포세포암, 비선암, 담도 유래 선암 등의 진단 - 선별 검사 방문과 무작위 배정 72시간 이내에 ECOG PS가 악화된 환자 - 조절되지 않거나 정맥 내 항생제가 필요한 심각한 전신 감염 - 인간면역결핍바이러스(HIV) 양성 이력 또는 만성/활동성 바이러스성 간염 이력 - 지난 6개월 이내의 심근경색, 관상동맥 우회술, 동맥혈전색전증, 심부전 등의 심혈관 질환 이력

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  1. A diagnosis of advanced and unresectable or metastatic pancreatic adenocarcinoma confirmed by:

  2. Histopathology from primary tumor in pancreas, OR

  3. Histopathology from a non-pancreatic lesion in the presence of a mass in the pancreas consistent with pancreatic adenocarcinoma or a medically documented history of pancreatic adenocarcinoma.
  4. Measurable disease per RECIST v.1.1

  5. Male or non-pregnant, non-lactating female, ≥18 years or age

  6. If a female patient is of child-bearing potential, as evidenced by menstrual periods, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β- hCG]) documented prior to the first administration of stud drugs

  7. Female patients of childbearing age and women \< 12 months since the onset of menopause must agree to use acceptable contraceptive methods for the duration of the study and 9 months following the last injection of OT-101.
  8. Male patients must use effective contraception for a duration of 6 months after the final dose, as per the prescribing information for oxaliplatin.
  9. Provide signed written informed consent
  10. Eastern Cooperative Group (ECOG) Performance Status (PS) score of 0-1
  11. Willingness and ability to comply with study requirements
  12. Patient has adequate organ function by the following laboratory assessments at baseline(obtained ≤28 days prior to Randomization):

Hematologic * Platelets ≥100×109/L * Hemoglobin ≥9.0 g/dL * Absolute Neutrophil Count (ANC) ≥1.5×109/L * Patient has acceptable coagulation values obtained ≤28 days prior to Randomization as demonstrated by prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤1.5× upper limit of normal (ULN) (if on Coumadin, patient must be changed to LMWH or on Factor II or Xa anticoagulant with a t½ of less than 24 hours

Hepatic * Aspartate transaminase (AST)/alanine transaminase (ALT) ≤3×ULN (if liver metastases are present, ≤5×ULN) * Alkaline phosphatase ≤2.0×ULN (if liver metastases are present, ≤5×ULN) * Total bilirubin ≤2.0×ULN (in patients with Gilbert's Syndrome total bilirubin \< or = 2.5xULN)

Renal * Calculated creatinine clearance ≥50 mL/min. Actual body weight should be used for calculating creatinine clearance (e.g., using the Modification of Diet in Renal Disease [MDRD] formula. For patients with a body mass index (BMI) >30 kg/m2, lean body weight should be used instead 8. Patient must have a life expectancy of ≥3 months in the opinion of the Investigator

Exclusion Criteria:

  1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (ie,lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
  2. Patient has experienced a decrease in ECOG PS between Screening visit and within 72 hours prior to Randomization
  3. Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with t½ of less than 24 hours
  4. History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer, or other cancers (eg, breast and prostate) for which the patient has been disease-free for at least 3 years. Patients with prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from the study
  5. Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for the study
  6. Patients with abnormal electrocardiogram (ECG) at baseline (QT or QTc interval >470 ms) will be excluded from this study. The eligibility of patients with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the Sponsor's medical representative in consultation with the principal investigator.
  7. Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
  8. Known history of positivity (regardless of immune status) for human immunodeficiency virus(HIV)
  9. Known history of chronic active or active viral hepatitis A, B, or C infection
  10. Clinically significant bleeding within 2 weeks prior to Randomization (eg, gastrointestinal[GI] bleeding or intracranial hemorrhage)
  11. Pregnant or lactating women
  12. Myocardial infarction, coronary bypass surgery, or arterial thromboembolic events within the last 6 months prior to Randomization, symptomatic congestive heart failure (New York Heart Association Classification >Class II, unstable angina, or unstable cardiac arrhythmia requiring medication
  13. Clinically significant ascites defined as requiring ≥1 paracentesis every 2 weeks
  14. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to Randomization or anticipated surgery during the study period
  15. Prior history of receiving immune checkpoint inhibitors (anti-CTLA4, anti-PD1, anti-PD-L1)
  16. Peripheral neuropathy (>Grade 1)
  17. Known history of dihydropyrimidine dehydrogenase deficiency (DPD) - Dihydropyrimidine dehydrogenase (DPD) is the initial and rate-limiting enzyme in the catabolism of 5-fluorouracil (5-FU). Thus, patients with a DPD deficiency are at risk of developing severe 5-FU-associated toxicity
  18. History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegner´s granulomatosis, Sjogren´s syndrome, Bell´s palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, except for psoriasis not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism

  19. Patients receiving any of the following medications are not eligible for study:

    1. Investigational agents other than the protocol drugs
    2. Anti-coagulants (except for heparin to maintain the patency of central venous catheters)
    3. Non-steroidal anti-inflammatory drugs
    4. Clopidogrel (Plavix), dipyridamole (Persantine), or any other drug that inhibits platelet functions
    5. Patients on greater than 2 mg dexamethasone, 10 mg Prednisone or or equivalent dose in alternate corticosteroid daily or actively undergoing corticosteroid dose escalation are NOT eligible

  20. History of allergic reactions or known hypersensitivity to compounds of similar chemical or biologic composition to OT-101 such as anti-sense oligonucleotides or siRNA

  21. Patients who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy. Telemedicine visits are acceptable
  22. Not willing and able to comply with study requirements including protocol mandated procedures and visits
  23. Other contraindications as defined in the product label of the components of the mFOLFIRINOX treatment regimen
  24. Participation in another investigational clinical trial within 30 days of receiving the last dose of investigational study drug
  25. Clinically significant psychiatric disorders, legal incapacity or limited legal capacity
  26. Patients with a primary immunodeficiency
  27. Patients with active central nervous system (CNS) metastases. (Patients with adequately treated CNS metastases who are clinically stable for at least 6 weeks after discontinuation of corticosteroids may be eligible for enrollment with the approval of the Sponsor's medical representative and the principal investigator)

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

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