임상 레이더 AI | ||
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임상시험 NCT07262619은(는) 진행된 고형 종양들, MSI-H or dMMR Advanced Solid Tumors, MSI-H/dMMR Gastric Cancer, MSI-H/dMMR Colorectal Cancer, MSI-H/dMMR Gastroesophageal-junction Cancer, 자궁내막암, Mismatch Repair Deficient or MSI-High Solid Tumors에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors 1상, 2상 160
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07262619은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 진행된 고형 종양들, MSI-H or dMMR Advanced Solid Tumors, MSI-H/dMMR Gastric Cancer, MSI-H/dMMR Colorectal Cancer, MSI-H/dMMR Gastroesophageal-junction Cancer, 자궁내막암, Mismatch Repair Deficient or MSI-High Solid Tumors에 대해 진행되며, 1상 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2026년 1월 22일에 시작되어 160명의 참여자를 모집하고 있습니다. Eikon Therapeutics이(가) 진행하며, 2029년 3월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 2일에 갱신되었습니다.
간단한 개요
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.
상세한 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 par...
더 보기공식 제목
A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors
질환명
진행된 고형 종양들MSI-H or dMMR Advanced Solid TumorsMSI-H/dMMR Gastric CancerMSI-H/dMMR Colorectal CancerMSI-H/dMMR Gastroesophageal-junction Cancer자궁내막암Mismatch Repair Deficient or MSI-High Solid Tumors기타 연구 식별자
- EIK1005-002
- 2026-525248-13-00 (EU 시험 (CTIS) 번호)
- KEYNOTE-G56 (기타 식별자) (Merck Sharp & Dohme LLC)
- MK-3475-G56 (기타 식별자) (Merck Sharp & Dohme LLC)
NCT 번호
실제 연구 시작일
2026-01-22
최신 업데이트 게시
2026-03-02
예상 연구 완료일
2029-03
계획된 등록 인원
160
연구종류
중재연구
단계/상
1상
2상
2상
상태
모집중
키워드
Werner helicase
WRN
MSI-H
dMMR
DNA mismatch repair
EIK1005
Advanced Solid Tumors
Metastatic
MSI-H/dMMR Endometrial Cancer
MSI-H/dMMR Prostate Cancer
Pembrolizumab
Mismatch Repair Deficient (dMMR)
Microsatellite Instability High (MSI-H)
WRN
MSI-H
dMMR
DNA mismatch repair
EIK1005
Advanced Solid Tumors
Metastatic
MSI-H/dMMR Endometrial Cancer
MSI-H/dMMR Prostate Cancer
Pembrolizumab
Mismatch Repair Deficient (dMMR)
Microsatellite Instability High (MSI-H)
주요 목적
치료
설계 할당
비랜덤화 배정
중재 모델
순차설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Part 1A (Dose escalation, Monotherapy) EIK1005 will be given as monotherapy in participants without alternative treatment options. | EIK1005 EIK1005 is a selective inhibitor of the Werner helicase. |
실험적Part 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. | EIK1005 EIK1005 is a selective inhibitor of the Werner helicase. pembrolizumab (KEYTRUDA® ) Pembrolizumab is a PD-1 inhibitor. |
실험적Part 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. | EIK1005 EIK1005 is a selective inhibitor of the Werner helicase. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Dose-Limiting Toxicity (DLT) - Part 1 | A DLT is a protocol-defined adverse event occurring during the DLT observation period. | 21 Days |
Adverse Events (AEs) - Part 1 and Part 2 | 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. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Objective Response (OR) - Part 1 and Part 2 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- is ≥ 18 years of age at the time of signing the informed consent.
- has a life expectancy of at least 3 months.
- 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.
- 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.
- has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI.
- has an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
- has an adequate organ and marrow function.
- has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs).
- has received prior treatment with Werner (WRN) inhibitor.
- 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.
- 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.
- has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- 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.
- has mean resting QTcF > 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).
- 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).
- has history of (non-infectious) pneumonitis/pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
- has active tuberculosis.
- has any active infections requiring systemic therapy.
Eikon Therapeutics머크연구 대표 연락처
연락처: Ana C Mamede, PharmD, 347-806-4584, [email protected]
연락처: Krishna Kaza, [email protected]
10 3개국에 임상시험 장소
New Jersey
Morristown Medical Center, Morristown, New Jersey, 07960, United States
대상자모집전
New York
Memorial Sloan Kettering Cancer Center (MSKCC), New York, New York, 10022, United States
대상자모집전
Texas
University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States
대상자모집전
New South Wales
GenesisCare North Shore (Oncology), Saint Leonards, New South Wales, Australia
대상자모집전
Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia
모집중
Victoria
Grampians Health, Ballarat, Victoria, Australia
모집중
Chris O'Brien Lifehouse (Sydney Cancer Centre), Camperdown, Victoria, Australia
대상자모집전
Oncology Clinics Victoria (OCV) - Cabrini Brighton Hospital, Frankston, Victoria, 3199, Australia
대상자모집전
Peninsula and Southeast Oncology (PASO) Medical, Frankston, Victoria, Australia
모집중
Health New Zealand, Wellington, New Zealand
대상자모집전