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EIK1005-002: 고형암 환자(마이크로새텔라이트 불안정성 고(Microsatellite Instability High, MSI-H) 종양 포함)를 대상으로 Werner 헬리카제 억제제인 EIK1005 단독요법 및 펨브롤리주맙과의 병용요법을 평가하는 임상 연구

2026년 10월 29일 업데이트: Eikon Therapeutics

국내외 다기관, 다부문, 1/2상 임상시험: EIK1005 단독요법 및 Pembrolizumab 병용요법이 진행성 고형암 환자, 특히 마이크로새텔라이트 불안정성 고(MSI-H) 또는 결합수복결핍(dMMR) 종양을 가진 체크포인트 억제제 미사용 환자에 미치는 효과 평가

The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This Phase 1/2 study (EIK1005-002) will investigate the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of EIK1005 as a monotherapy and in combination with pembrolizumab in participants with advanced solid tumors, including participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors.

The study will be conducted in 2 parts: Part 1 and Part 2, with Part 1 being further divided into Part 1A and Part 1B as described below:

  • Part 1A (monotherapy dose escalation): participants will receive EIK1005 only.
  • Part 1B (combination dose escalation): participants will receive EIK1005 in combination with pembrolizumab.
  • Part 2 (dose optimization): participants will be randomized 1:1 to monotherapy with EIK1005 at one of the two selected doses from Part 1A to identify the dose of EIK1005 in monotherapy for subsequent studies.

연구 유형

중재적

등록 (추정된)

160

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 노르웨이
      • Oslo, 노르웨이, 0379
        • 모병
        • Oslo University
  • 뉴질랜드
      • Wellington, 뉴질랜드
        • 모병
        • Health New Zealand
    • Manawatu
      • Roslyn, Manawatu, 뉴질랜드, 4414
        • 모병
        • Palmerstone North Hospital
  • 대한민국
      • Seoul, 대한민국, 02841
        • 모병
        • Korea University Anam Hospital
      • Suwon, 대한민국, 16499
        • 모병
        • Ajou University School of Medicine & Graduate School of Medicine
    • Busan
      • Busan, Busan, 대한민국, 48108
        • 모병
        • Inje University-Haeundae Paik Hospital
  • 독일
      • Berlin, 독일, 13125
        • 모병
        • Helios Klinikum Berlin-Buch
      • Hamburg, 독일, 22297
        • 모병
        • Norddeutsches Studienzentrum fur Innovative Onkologie (NIO) Hamatologisch Onkologische Praxis Eppendorf (HOPE)
    • Bavaria
      • Deggendorf, Bavaria, 독일, 94469
        • 모병
        • DONAUISAR Klinikum
  • 미국
    • California
      • Los Angeles, California, 미국, 90027
        • 모병
        • California Research Institute (CRI)
    • Florida
      • Doral, Florida, 미국, 33172
        • 모병
        • Omnicure Clinical Research
      • Hialeah, Florida, 미국, 33013
        • 모병
        • Bioresearch Partner
      • Plantation, Florida, 미국, 33322
        • 모병
        • Florida Clinical Trials Group
      • Tamarac, Florida, 미국, 33321
        • 모병
        • Florida Clinical Trials Group - Tamarac
    • New Jersey
      • Morristown, New Jersey, 미국, 07960
        • 모병
        • Morristown Medical Center
    • New York
      • Lake Success, New York, 미국, 11042
        • 모병
        • START New York-Long Island
      • New York, New York, 미국, 10022
        • 모병
        • Memorial Sloan Kettering Cancer Center (MSKCC)
    • Texas
      • Fort Worth, Texas, 미국, 76104
        • 모병
        • START Dallas Fort Worth
      • Houston, Texas, 미국, 77030
        • 모병
        • University of Texas MD Anderson Cancer Center
  • 벨기에
      • Brussels, 벨기에, 1020
        • 모병
        • Centre Hospitalier Universitaire Brugmann - Victor Horta
  • 스페인
      • Barcelona, 스페인, 08023
        • 모병
        • START - Barcelona
      • Logroño, 스페인, 26006
        • 모병
        • START Rioja - Hospital de San Pedro
      • Madrid, 스페인, 28233
        • 모병
        • NEXT Madrid HUQSM
      • Zaragoza, 스페인, 50009
        • 모병
        • Hospital Universitario Miguel Servet
    • Balearic Islands
      • Palma, Balearic Islands, 스페인, 07120
        • 모병
        • Hospital Universitari Son Espases
    • Barcelona
      • Barcelona, Barcelona, 스페인, 8036
        • 모병
        • Hospital Clinic Barcelona
  • 싱가포르
      • Singapore, 싱가포르, 119074
        • 모병
        • National University Hospital (NUH)
    • Central Region
      • Singapore, Central Region, 싱가포르, 168583
        • 모병
        • National Cancer Centre Singapore (NCCS)
  • 오스트리아
      • Linz, 오스트리아, 4020
        • 모병
        • Ordensklinikum Linz Elisabethinen
  • 이탈리아
      • Rome, 이탈리아, 00128
        • 모병
        • Campus Bio-Medico di Rome University
  • 포르투갈
      • Lisbon, 포르투갈, 1649-028
        • 모병
        • Hospital de Santa Maria
      • Loures, 포르투갈, 2674-514
        • 모병
        • Unidade Local de Saúde (ULS) Loures Odivelas
      • Porto, 포르투갈, 4200
        • 모병
        • Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. (IPO Porto)
    • Lisbon District
      • Lisbon, Lisbon District, 포르투갈, 1500-650
        • 모병
        • Hospital da Luz Lisboa
  • 폴란드
      • Krakow, 폴란드, 31-864
        • 모병
        • GCPMED Sp. z o.o., Centrum Medyczne iMed24
      • Lodz, 폴란드, 90-338
        • 모병
        • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, 폴란드, 70-419
        • 모병
        • One Day Med
  • 프랑스
    • Rhone
      • Pierre-Bénite, Rhone, 프랑스, 69310
        • 모병
        • Hospices Civils De Lyon (hcl) -Centre Hospitalier Lyon-Sud
  • 핀란드
      • Kuopio, 핀란드, 70210
        • 모병
        • Kuopio University Hospital
  • 호주
    • New South Wales
      • Saint Leonards, New South Wales, 호주
        • 아직 모집하지 않음
        • GenesisCare North Shore (Oncology)
      • Waratah, New South Wales, 호주
        • 모병
        • Calvary Mater Newcastle Hospital
    • Victoria
      • Ballarat, Victoria, 호주
        • 모병
        • Grampians Health
      • Camperdown, Victoria, 호주
        • 모병
        • Chris O'Brien Lifehouse (Sydney Cancer Centre)
      • Frankston, Victoria, 호주
        • 모병
        • Peninsula and Southeast Oncology (PASO) Medical
      • Frankston, Victoria, 호주, 3199
        • 모병
        • Oncology Clinics Victoria (OCV) - Cabrini Brighton Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Key Inclusion Criteria:

  1. is ≥ 18 years of age at the time of signing the informed consent.
  2. has a life expectancy of at least 3 months.
  3. has histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor. Part 1A: recommend that participants have archival tissue not more than 3 years old. Part 1B and Part 2: participant has locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumor. Participant must have archival tumor tissue (not more than 3 years old) for retrospective confirmation of MSI-H or dMMR tumor by a central laboratory.
  4. In Part 1A, has received and then progressed after or is intolerant to at least 1 standard treatment regimen in the advanced setting. The participant does not have alternative therapeutic options per PI's medical judgement. Preference should be given to: (1) participants with MSI-H or dMMR cancers that have progressed after checkpoint inhibitor (CPI) therapy and (2) participants with microsatellite stable cells (MSS) cancers that have progressed following at least one regimen of platinum, alkylating or topoisomerase containing chemotherapy.
  5. has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI.
  6. has an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
  7. has an adequate organ and marrow function.

Key Exclusion Criteria:

  1. has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs).
  2. has received prior treatment with Werner (WRN) inhibitor.
  3. has a history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients, history of serious allergic reactions leading to hospitalization, or any other allergic reaction in general.
  4. In Parts 1B and Part 2 Rescue: diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
  5. has known additional malignancy that is progressing or has required active treatment within the past 3 years.
  6. has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment.
  7. has mean resting QTcF > 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).
  8. has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Participants may enroll with the following conditions: Type 1 diabetes, hypothyroidism requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia not requiring systemic treatment).
  9. has history of (non-infectious) pneumonitis/pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
  10. has active tuberculosis.
  11. has any active infections requiring systemic therapy.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Part 1A (Dose escalation, Monotherapy)

EIK1005 will be given as monotherapy in participants without alternative treatment options.
의약품: EIK1005

EIK1005 is a selective inhibitor of the Werner helicase.
실험적: Part 1B (Dose escalation, Combination with pembrolizumab)

EIK1005 will be given in combination with pembrolizumab to participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) solid tumors.
의약품: EIK1005

EIK1005 is a selective inhibitor of the Werner helicase.

의약품: pembrolizumab (KEYTRUDA® )

Pembrolizumab is a PD-1 inhibitor.
실험적: Part 2 (Dose optimization, Monotherapy)

Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced solid tumors will be randomized to receive EIK1005 monotherapy at one of the two identified doses selected from Part 1A.
의약품: EIK1005

EIK1005 is a selective inhibitor of the Werner helicase.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Dose-Limiting Toxicity (DLT) - Part 1
기간: 21 Days

A DLT is a protocol-defined adverse event occurring during the DLT observation period.
21 Days
Adverse Events (AEs) - Part 1 and Part 2
기간: From the time of first dose of study medication through 30 days following cessation of study treatment.

Number of participants reporting adverse events or serious adverse events.
From the time of first dose of study medication through 30 days following cessation of study treatment.

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response (OR) - Part 1 and Part 2
기간: Through study completion, an average of 2 years.

OR defined as participants who have a complete response [CR] or partial response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 as assessed by the Investigator.
Through study completion, an average of 2 years.
Duration of Response (DOR) - Part 1 and Part 2
기간: Through study completion, an average of 2 years.

DOR (defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR) by RECIST 1.1 as assessed by the Investigator.
Through study completion, an average of 2 years.
Disease Control (DC) - Part 1 and Part 2
기간: Through study completion, an average of 2 years.

DC defined as participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) by RECIST 1.1 as assessed by the Investigator.
Through study completion, an average of 2 years.
Progression-free survival (PFS) - Part 2
기간: Through study completion, an average of 2 years.

PFS defined as the time from randomization to the first documented disease progression by RECIST 1.1 as assessed by the Investigator or death due to any cause, whichever occurs first.
Through study completion, an average of 2 years.
Pharmacokinetic (PK) parameters of EIK1005 - AUC0-24 (Part 1 and Part 2)
기간: Up to 1 year

AUC0-24 (Area Under the plasma Concentration versus time curve from 0 to 24 hours): Measures total drug exposure over the first 24 hours after dosing of EIK1005 as monotherapy and in combination with pembrolizumab.
Up to 1 year
Pharmacokinetic (PK) parameters of EIK1005 - AUCtau,ss (Part 1 and Part 2)
기간: Up to 1 year

AUCtau,ss [Area Under the plasma Concentration versus time curve over one dosing interval (tau) at steady state]: Reflects average drug exposure during each dosing interval once the steady state has been reached for EIK1005 as monotherapy and in combination with pembrolizumab.
Up to 1 year
Pharmacokinetic (PK) parameters of EIK1005 - Cmax (Part 1 and Part 2)
기간: Up to 1 year

Cmax (Maximum Plasma Concentration) after dose administration of EIK1005 as monotherapy and in combination with pembrolizumab.
Up to 1 year
Pharmacokinetic (PK) parameters of EIK1005 - tmax (Part 1 and Part 2)
기간: Up to 1 year

tmax (the time required for the plasma concentration of the drug to reach maximum concentration after dose administration) of EIK1005 as monotherapy and in combination with pembrolizumab.
Up to 1 year
Pharmacokinetic (PK) parameters of EIK1005 - t½ (Half-life) (Part 1 and Part 2)
기간: Up to 1 year

Half-life (the time required for the plasma concentration of the drug to decrease by 50% after the dose administration) of EIK1005 as monotherapy and in combination with pembrolizumab.
Up to 1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eikon Therapeutics

협력자

Merck Sharp & Dohme LLC

수사관

  • 연구 책임자: Nilou Mobashery, MD, Eikon Therapeutics, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 1월 20일

기본 완료 (추정된)

2029년 3월 1일

연구 완료 (추정된)

2029년 3월 1일

연구 등록 날짜

최초 제출

2025년 11월 10일

QC 기준을 충족하는 최초 제출

2025년 12월 1일

처음 게시됨 (실제)

2025년 12월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • EIK1005-002
  • 2026-525248-13-00 (씨티스)
  • KEYNOTE-G56 (기타 식별자: Merck Sharp & Dohme LLC)
  • MK-3475-G56 (기타 식별자: Merck Sharp & Dohme LLC)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다