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진행성 고형암 환자를 대상으로 한 MDNA11 단독 요법 및 펨브롤리주맙 병용 요법의 1/2상 임상시험

A Beta-only IL-2 ImmunoTherapY Study

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 NCT05086692
상태 모집 중
단계 1상/2상
시험 약물/중재 MDNA11, Pembrolizumab (KEYTRUDA®)
대상 질환 Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer Squamous, Non-Small Cell Lung Cancer Non-squamous
스폰서 Medicenna Therapeutics, Inc.
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 115
시작 / 1차 완료 예정 2021-08-27 / 2026-06-30
국내 실시기관 Samsung Medical Center(Seoul), Seoul National University Bundang Hospital(Seongnam-si), The Catholic University of Korea St. Vincent Hospital(Suwon), Seoul National University Hospital(Seoul)
실시 국가 7개국, 기관 27곳 (Australia, Canada, Ireland, Portugal, South Korea, Spain, United States)
결과 게시 아니오
최근 갱신 2025-07-09

문의처 (등록된 중앙 연락처)

  • Nina Merchant 604-340-3081 nmerchant@medicenna.com
  • Melissa Coello 267-476-2313 mcoello@medicenna.com

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

시험 개요

이 임상시험은 진행성 고형암 환자를 대상으로 지속형 베타 전용 인터루킨-2(rIL-2) 신약인 MDNA11의 단독 요법 또는 면역관문억제제(pembrolizumab)와의 병용 요법 안전성과 내인성, 약동학 및 항종양 활성을 평가합니다. 연구는 용량 증량 및 확장 단계로 진행되며 목표 환자 수는 약 115명입니다. CT 또는 MRI를 통한 종양 평가는 질병 진행이 확인될 때까지 8주마다 수행됩니다.

  • 목표 인원은 약 115명이며 국내 4곳의 기관이 참여합니다.
  • MDNA11은 암세포를 사멸하는 면역 효과 세포를 활성화하도록 설계된 베타 전용 재조합 인터루킨-2(rIL-2)입니다.
  • 치료 효과 평가는 CT나 MRI를 통해 8주(±1주) 간격으로 진행됩니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준:- 만 18세 이상- 동부종양학협력그룹(ECOG) 수행능력 평가 0 또는 1- 서면 동의서 작성 가능자- 조직학적으로나 세포학적으로 확진된 국소 진행성 또는 전이성 고형암- 적절한 장기 기능 보유- 고형암 반응평가기준(RECIST v1.1)에 따른 측정 가능한 병변 존재- 예상 여명 12주 이상제외 기준:- 치료 시작 전 4주 이내의 전신 항암 치료 또는 임상시험용 의약품 투여 이력- 2주 이내의 방사선 치료 이력 또는 방사선 폐렴 병력- 활성 중추신경계(CNS) 전이 및/또는 수막 암종증 존재- 최근 3년 이내의 다른 활성 악성 종양- 면역억제제 또는 고용량 코르티코스테로이드의 장기 치료 필요 환자

선정/제외 기준 원문 (영어)

Key Inclusion Criteria:

  1. Aged at least 18 years (inclusive at the time of informed consent).
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
  4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
  5. Demonstrated adequate organ function
  6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
  7. Life expectancy of ≥ 12 weeks.
  8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.
  9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.

Key Exclusion Criteria:

  1. Last administration of prior antitumor therapy:

  2. Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.

  3. Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\<2 weeks of radiotherapy) to non-CNS disease.
  4. Radiation therapy to the lung that is > 30Gy within 6 months prior to start of treatment.
  5. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.
  6. Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.
  7. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
  8. Condition requiring long-term systemic treatment with either corticosteroids > 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.
  9. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
  10. Severe pulmonary, cardiac or other systemic disease.
  11. Known hepatitis B or C virus infection.
  12. Females who are pregnant or lactating or planning to become pregnant during the study.
  13. Has had an allogeneic tissue/solid organ transplant.
  14. Active infection requiring systemic therapy.
  15. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol
  16. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.
  17. Known severe hypersensitivity to any component of study drug(s).
  18. Inability to comply with study and follow up procedures as judged by the Investigator.

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

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