치료 이력이 없는 전이성 췌장관암 환자를 대상으로 Zunsemetinib과 mFOLFIRINOX 병용 요법을 평가하는 1상 임상시험

MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma

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	NCT06648434
상태	모집 중
단계	1상
시험 약물/중재	Zunsemetinib, mFOLFIRINOX
대상 질환	Metastatic Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Cancer of the Pancreas
스폰서	Washington University School of Medicine
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	51
시작 / 1차 완료 예정	2025-06-13 / 2027-06-30
국내 실시기관	없음
실시 국가	1개국, 기관 1곳 (United States)
결과 게시	아니오
최근 갱신	2026-04-30

문의처 (등록된 중앙 연락처)

• Moh'd Khushman, M.D. 314-273-3564 mkhushman@wustl.edu

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

시험 개요

본 연구는 전이성 췌장관암(metastatic pancreatic ductal adenocarcinoma, PDAC) 환자를 대상으로 MK2 억제제인 zunsemetinib과 mFOLFIRINOX 항암화학요법을 병용 투여하는 1상 임상시험입니다. 연구자들은 MK2 억제가 mFOLFIRINOX 화학요법의 효능을 향상시킬 수 있을 것으로 가정합니다. 목표 환자 수는 51명이며, 워싱턴 대학교 의과대학(Washington University School of Medicine)에서 진행 중입니다. 초록에 구체적인 생존기간이나 반응률 등의 수치는 명시되지 않았습니다.

• 대상 질환은 치료 이력이 없는 전이성 췌장관암(metastatic pancreatic ductal adenocarcinoma)입니다.
• 시험 중인 약물은 MK2 억제제인 zunsemetinib과 mFOLFIRINOX의 병용 요법입니다.
• 목표 환자 수는 51명이며 1상(phase 1) 단계로 현재 환자를 모집 중입니다.
• 구체적인 생존기간, 반응률, 위험비 등의 결과 수치는 초록에 명시되지 않았습니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 조직학적 또는 세포학적으로 확진된 전이성 췌장관암 환자 - 진행성 또는 전이성 질환에 대한 이전 전신 치료력이 없는 환자 (단, 마지막 투여 후 12개월 이상 지난 보조/선행보조 치료는 허용) - RECIST 1.1 기준에 따른 측정 가능한 병변 존재 - 만 18세 이상 - ECOG 수행 능력 상태 0 또는 1 이하 - 적절한 골수 및 장기 기능 보유 (절대호중구수 1.5 K/cumm 이상, 혈소판 100 K/cumm 이상, 혈색소 9.0 g/dL 이상 등) 제외 기준: - 2년 이내에 치료가 완료되지 않았거나 질병 증거가 있는 다른 악성종양 병력 - 동종 장기 또는 줄기세포 이식 병력 - 현재 다른 임상시험용 약물을 투여 중이거나 2주 또는 5반감기 이내에 투여받은 경우 - 강력한 및 중등도의 CYP3A4/CYP2C8 억제제/유도제 및 QT 연장 가능 약물 복용자 - 알려진 뇌 전이 또는 중추신경계 침범 - 임신 중이거나 수유 중인 여성

선정/제외 기준 원문 (영어)

Inclusion Criteria:

• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma with no prior systemic treatment for advanced or metastatic disease. Patients with mixed cytology in their tumors such as adeno-squamous, mixed neuroendocrine-carcinoma are permitted if the portion of adenocarcinoma is predominant. Prior adjuvant/neoadjuvant therapy (including FOLFIRINOX or mFOLFIRINOX regimens) is allowed if progression occurred ≥ 12 months from the last dose of that therapy. A biopsy is not required to confirm advanced or metastatic disease.
• Dose escalation: Diagnosis of advanced inoperable or metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician.
• Dose expansion: Diagnosis of metastatic disease, where mFOLFIRINOX (or classical FOLFIRINOX) is deemed a suitable option per the treating physician.
• Measurable disease by RECIST 1.1.
• At least 18 years of age
• ECOG performance status ≤ 1.

• Adequate bone marrow and organ function as defined below:

• Absolute neutrophil count ≥ 1.5 K/cumm

• Platelets ≥ 100 K/cumm without transfusion within 2 weeks prior to C1D1
• Hemoglobin ≥ 9.0 g/dL without transfusion within 2 weeks prior to C1D1
• Total bilirubin ≤ 1.5 x IULN
• AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN
• Creatinine clearance > 50 mL/min by Cockcroft-Gault
• Baseline EKG with QTcF ≤ 460 ms.
• Women of childbearing potential and men who are heterosexually active must agree to use adequate contraception as specified in the protocol. Contraception should continue for 1 month following last dose of zunsemetinib, 6 months following last dose of irinotecan, 9 months following last dose of oxaliplatin, and/or 3 months following last dose of fluorouracil. Should a woman (or the female partner of a male participant) become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic pancreatic cancer.
• History of allogeneic organ or stem cell transplant.
• Currently receiving any other investigational agents, or receipt of an investigational agent within 2 weeks or 5 half-lives of the agent, whichever is shorter.
• Receipt of strong and moderate CYP3A4 and CYP2C8 inhibitors (including grapefruit), strong and moderate CYP3A and CYP2C8 inducers (see Appendices H and I), and drugs with QT prolonging potential within 5 half-lives of cycle 1 day 1.
• Known brain metastases or CNS involvement, because brain metastases are often associated with poor functional status, shortened life expectancy and risk of toxicity.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to zunsemetinib, or other agents used in the study.
• Clinically significant neuropathy ≥ grade 2.
• Presence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.
• Gastrointestinal conditions which could prevent absorption of zunsemetinib, in the opinion of the treating physician.
• Inability to swallow pills.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia .
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days of C1D1.
• Patients with HIV are eligible unless their CD4+ T-cell counts are \< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
• Major surgery within 28 days prior to C1D1. Major surgery refers to any surgical procedure that involves general or regional anesthesia, involves extensive resecting or altering of body parts, carries a higher risk of complications, or requires long recovery times. Central line placement is allowed.
• Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of C1D1.

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

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