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임상시험 NCT07247110은(는) 악성 신생물에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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머크A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) 1상 250
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 NCT07247110은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 악성 신생물에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 12월 16일에 시작되어 250명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2030년 12월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.
공식 제목
A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors
질환명
악성 신생물기타 연구 식별자
- 4716-001
- 2025-522495-84 (등록 식별자) (EU CT)
- U1111-1323-3663 (등록 식별자) (UTN)
- MK-4701-001 (기타 식별자) (MSD)
NCT 번호
실제 연구 시작일
2025-12-16
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2030-12-01
계획된 등록 인원
250
연구종류
중재연구
단계/상
1상
상태
모집중
주요 목적
치료
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적MK-4716 Dose Escalation Participants receive MK-4716 at varying dose levels and schedules. | MK-4716 Oral administration |
실험적MK-4716 + Pembrolizumab Participants will receive MK-4716 + Pembrolizumab | MK-4716 Oral administration Pembrolizumab Intravenous administration |
실험적MK-4716 + Cetuximab Participants will receive MK-4716 + Cetuximab | MK-4716 Oral administration Cetuximab Intravenous administration |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) | A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness. | Up to approximately 28 days |
Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 5 years |
Number of Participants Who Discontinue Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. | Up to approximately 5 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Area Under the Concentration-Time Curve (AUC) of MK-4716 | Blood samples will be collected to determine the AUC of MK-4716. | At designated timepoints (up to approximately 58 days) |
Maximum Plasma Concentration (Cmax) of MK-4716 | Blood samples will be collected to estimate Cmax of MK-4716. | At designated timepoints (up to approximately 58 days) |
Trough Plasma Concentration (Ctrough) of MK-4716 | Blood samples will be collected to determine the Ctrough of MK-4716. | At designated timepoints (up to approximately 19 months) |
Half-Life (t1/2) of MK-4716 | Blood samples will be collected to determine the t1/2 of MK-4716. | At designated timepoints (up to approximately 58 days) |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration
- Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease
- Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer
- Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration
- Arm MK-4716 + Pembrolizumab: Must be untreated
- Has measurable disease
- Has the ability to swallow and retain oral medication
- Arm MK-4716 + Pembrolizumab: Has a 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
- Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment
- Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- History of human immunodeficiency virus infection
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has a known active central nervous system metastases and/or carcinomatous meningitis
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has Hepatitis B or Hepatitis C virus infection
- History of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
머크연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
14 6개국에 임상시험 장소
Seoul National University Hospital ( Site 0501), Seoul, 03080, South Korea
Study Coordinator, 연락처, 82-2-2072-0242
모집중
Asan Medical Center ( Site 0502), Seoul, 05505, South Korea
Study Coordinator, 연락처, 82-2-3010-1727
모집중
New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0052), New Brunswick, New Jersey, 08903, United States
Study Coordinator, 연락처, 732-253-3939
모집중
Texas
NEXT Oncology ( Site 0051), Irving, Texas, 75039, United States
Study Coordinator, 연락처, 972-893-8800
모집중
Virginia
NEXT Virginia ( Site 0054), Fairfax, Virginia, 22031, United States
Study Coordinator, 연락처, 703-783-4510
모집중
Western Australia
One Clinical Research ( Site 0454), Nedlands, Western Australia, 6009, Australia
Study Coordinator, 연락처, +61862799466
모집중
Region M. de Santiago
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103), Santiago, Region M. de Santiago, 8330073, Chile
Study Coordinator, 연락처, +56934331806
모집중
Bradfordhill ( Site 0102), Santiago, Region M. de Santiago, 8420383, Chile
Study Coordinator, 연락처, +56229490970
모집중
Rambam Health Care Campus ( Site 0252), Haifa, 3109601, Israel
Study Coordinator, 연락처, +97247772688
모집중
Rabin Medical Center ( Site 0253), Petah Tikva, 4941492, Israel
Study Coordinator, 연락처, +97239377377
모집중
Sheba Medical Center ( Site 0251), Ramat Gan, 5265601, Israel
Study Coordinator, 연락처, +97235303030
모집중
Hospital General Universitari Vall d Hebron ( Site 0360), Barcelona, 08035, Spain
Study Coordinator, 연락처, +34932746000
모집중
Hospital Clinic de Barcelona ( Site 0362), Barcelona, 08036, Spain
Study Coordinator, 연락처, +34932274208
모집중
Hospital Universitario Fundacion Jimenez Diaz ( Site 0361), Madrid, 28040, Spain
Study Coordinator, 연락처, +34915504800x2805
모집중