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HER2 발현 고형암 환자를 대상으로 하는 zanidatamab 2상 임상시험

A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors

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 NCT06695845
상태 모집 중
단계 2상
시험 약물/중재 Zanidatamab
대상 질환 Breast Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Cancer, Colorectal Cancer, Endometrial Cancer
스폰서 Jazz Pharmaceuticals
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 200
시작 / 1차 완료 예정 2025-01-14 / 2026-12-31
국내 실시기관 National Cancer Center Suwon(Suwon), The Catholic University of Korea St Vincent's Hospital(Suwon), Chonnam National University Hwasun Hospital(Hwasun-Eup), Samsung Medical Center(Gangnam-gu), Korea University Guro Hospital(Guro-gu), Seoul National University Hospital(Jongno-gu), Severance Hospital(Seodaemun-gu), The Catholic University of Korea Seoul St. Mary's Hospital(Seoul), Asan Medical Center(Seoul), Seoul National University Bundang Hospital(Seoul)
실시 국가 3개국, 기관 28곳 (South Korea, Spain, United States)
결과 게시 아니오
최근 갱신 2026-07-10

문의처 (등록된 중앙 연락처)

  • Clinical Trial Disclosure & Transparency 215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

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

시험 개요

이 연구는 HER2(Human Epidermal Growth Factor Receptor 2) 면역조직화학(IHC) 3+ 과발현이 있는 국소 진행성, 절제 불가능 또는 전이성 고형암 환자들을 대상으로 zanidatamab(자니다타맙)의 효능과 안전성을 평가합니다. 이전에 치료받은 경험이 있는 환자들을 대상으로 진행됩니다. 목표 인원은 200명이며 국내 10곳의 기관이 참여합니다. 초록에 세부 생존기간이나 반응률 결과는 명시되지 않았습니다.

  • 목표 인원은 200명이며 국내 10개 기관이 참여합니다.
  • HER2 IHC 3+ 과발현이 확인된 고형암 환자를 대상으로 합니다.
  • 효능과 안전성을 평가하는 2상(Phase 2) 임상시험입니다.
  • 구체적인 생존기간이나 반응률 수치는 초록에 명시되지 않았습니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 만 18세 이상 성인 - 1차 이상의 전신 치료 후 진행된 국소 진행성, 절제 불가능 또는 전이성 고형암 환자 (담도암 제외) - 스폰서 지정 중앙 실험실에서 확인된 HER2 과발현(IHC 3+) - 중앙 HER2 검사를 위한 적절한 종양 검체 제출 가능 환자 - RECIST 1.1 기준에 따른 최소 1개 이상의 측정 가능한 병변 존재 - ECOG 수행 능력 상태 0 또는 1 - 예상 여명 3개월 이상 - 치료 후 안정화된 중추신경계(CNS) 전이가 있는 환자 참여 가능 - 적절한 장기 기능 보유 - 가임 여성의 경우 임신테스트 음성 제외 기준: - 软수막 질환 또는 미치료 뇌 전이 환자 - 조절되지 않거나 유의미한 심혈관 질환 환자 - 이전 암 치료와 관련된 지속적인 독성 보유 환자 - 조절되지 않는 감염 환자 - 알려진 HIV, 활동성 B형 또는 C형 간염, 활성 SARS-CoV-2 감염 환자 - 단일클론항체 등에 대한 생명을 위협하는 과민반응 병력 - 이전에 zanidatamab 투여를 받은 적이 있는 환자 - 대장암(CRC) 환자 중 알려진 KRAS/NRAS 및 BRAF 변이 보유자 - 임신 중이거나 모유 수유 중인 여성

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  1. Is at least 18 years of age inclusive at the time of signing the informed consent
  2. Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.
  3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.
  4. All participants must have adequate tumor sample for submission to allow central HER2 testing.
  5. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
  6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Has a life expectancy of at least 3 months, in the opinion of the investigator.

  8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:

  9. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.

  10. Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to \< Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment > 7 days prior to Cycle 1 Day 1.
  11. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.
  12. Adequate organ functions.
  13. Females of childbearing potential must have a negative pregnancy test result.
  14. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Exclusion Criteria:

  1. Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
  2. Has uncontrolled or significant cardiovascular disease
  3. Has ongoing toxicity related to prior cancer therapy
  4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
  5. Has known Human Immunodeficiency Virus (HIV) infection.
  6. Has active hepatitis B or C infection.
  7. Has an active SARS-CoV-2 infection.
  8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
  9. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.
  10. Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.
  11. Prior treatment with HER2-targeted therapy (Cohort 1 only).
  12. Has a history of trauma or major surgery
  13. Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
  14. Received zanidatamab at any time prior to the current study.
  15. Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
  16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
  17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
  18. Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.

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

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