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진행성 췌장암 환자에서 1차 치료로서 항암화학요법과 병용한 AK104 연구

A Study of AK104 With Chemotherapy as First-line Treatment in Patients With 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 NCT05859750
상태 모집 중
단계 2상
시험 약물/중재 AK104, AK104, Gemcitabine, Nab-Paclitaxel, Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate, Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin
대상 질환 Pancreatic Cancer
스폰서 Akeso
연령·성별 18 Years ~ 75 Years · ALL
목표 인원 78
시작 / 1차 완료 예정 2023-05-25 / 2025-06
국내 실시기관 없음
실시 국가 1개국, 기관 7곳 (China)
결과 게시 아니오
최근 갱신 2024-12-16

문의처 (등록된 중앙 연락처)

  • Zhifang Yao, MD +86-0760-89873999 clinicaltrials@akesobio.com

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

시험 개요

이 연구는 진행성 절제 불가능 또는 전이성 췌장관선암(pancreatic ductal adenocarcinoma) 환자를 대상으로 PD-1/CTLA-4 이중특이항체(bispecific antibody)인 AK104와 항암화학요법을 병용한 1차 치료의 안전성, 내약성, 약동학(pharmacokinetics, PK), 면역원성, 약력학(pharmacodynamics, PD) 및 항종양 활성을 평가하기 위한 다기관, 공개, 2상 임상시험입니다. 목표 환자 수는 78명이며, 연령은 18세부터 75세까지입니다. 초록에 명시되지 않음

  • 임상시험 단계: 2상(PHASE2)
  • 목표 환자 수: 78명
  • 대상 환자 연령: 18세~75세
  • 중재 치료: AK104, Gemcitabine, Nab-Paclitaxel, Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate, Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 18세 이상 75세 이하의 성인 - 조직학적 또는 세포학적으로 확진된 췌장관선암(PDAC) - 국소 진행성 또는 전이성 췌장암에 대해 이전에 전신 치료를 받지 않은 환자 - RECIST v1.1 기준에 따른 측정 가능한 종양 병소가 최소 1개 이상인 환자 - 동부협력종양군(ECOG) 활동도 점수가 0 또는 1인 환자 - 예상 생존기간이 3개월 이상인 환자

제외 기준: - 선방세포암(acinar cell carcinoma), 췌장 신경내분비종양(pancreatic neuroendocrine neoplasms), 췌장모세포종(pancreatoblastoma) 등 다른 병리학적 유형 - 활성 또는 치료되지 않은 뇌 전이, 수막 전이, 척수 압박 등이 있는 환자 - 알려진 생식세포 BRCA1/2 돌연변이가 있는 환자 - 빈번한 배액이 필요한 임상적으로 증상이 있는 흉수, 심낭수, 복수가 있는 환자 - 이전에 종양 면역 기전을 표적 하는 치료를 받은 적이 있는 환자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
  2. Males or females aged ≥ 18 years and ≤ 75 years at the time of signing the ICF.
  3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
  4. Patients have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer; for patients who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant/neoadjuvant chemotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
  5. Patients have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Expected survival ≥ 3 months.
  8. Patients who have adequate organ function.
  9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose. Male patients with female partners of childbearing potential must agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.

Exclusion Criteria:

  1. Histologically or cytologically confirmed other pathological types, such as acinar cell carcinoma, pancreatic neuroendocrine neoplasms or pancreatoblastoma.
  2. Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
  3. Patients with known germ line BRAC1/2 mutation.
  4. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
  5. Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
  6. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors.
  7. Major surgery other than the diagnosis of pancreatic cancer within 28 days prior to the first dose or major surgery is expected during the study.
  8. Pregnant or lactating women.
  9. Patients who received any prior treatments targeting the mechanism of tumor immunity.
  10. Patients with known contraindications to prescribed chemotherapy regimen (see instructions for specific drug).
  11. Patients with known medical history of severe hypersensitivity reactions to other monoclonal antibodies or intravenous gamma globulin.
  12. Active autoimmune disease within 2 years prior to the start of study treatmen.
  13. Known active pulmonary tuberculosis.
  14. Patients with active hepatitis B or active hepatitis C.
  15. Known medical history of immunodeficiency or positive HIV test.
  16. Patients with active infection.
  17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  18. Concurrent participation in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.
  19. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug, or would interfere with the evaluation of the study drug or the safety of patients, or the interpretation of the study results.

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

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