고급 단계 고형 종양을 가진 참가자의 JNJ-95437446 연구
고급 단계 고형 종양을 가진 참가자의 JNJ-95437446의 1 상 연구
The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
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Seoul, 대한민국, 03722
- 모병
- Severance Hospital Yonsei University Health System
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Florida
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Sarasota, Florida, 미국, 34232
- 모병
- Florida Cancer Specialists
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New York
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New York, New York, 미국, 10032
- 모병
- Columbia University Medical Center Herbert Irving Pavilion
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Tennessee
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Nashville, Tennessee, 미국, 37203
- 모병
- Tennessee Oncology
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Virginia
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Fairfax, Virginia, 미국, 22031
- 모병
- NEXT Oncology
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Barcelona, 스페인, 8035
- 모병
- Hosp Univ Vall D Hebron
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Madrid, 스페인, 28041
- 모병
- Hosp. Univ. 12 de Octubre
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Madrid, 스페인, 28040
- 모병
- Hosp Univ Fund Jimenez Diaz
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Madrid, 스페인, 28050
- 모병
- Hosp Univ Hm Sanchinarro
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma
- Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth factor receptor (EGFR) mutational status for NSCLC and Kirsten rat sarcoma/neuroblastoma ras viral oncogene/v-raf murine sarcoma oncogene B1 (KRAS/NRAS/BRAF) mutation status for CRC
- Have measurable or evaluable disease:
- Part 1: Either measurable or evaluable disease; Part 2: At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version (v) 1.1
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening
- Participants must have appropriate hematologic, renal, and hepatic function within the required limits
Exclusion Criteria:
- Any prior medical history of ILD/pneumonitis, including pneumonitis from anti-PD-1/ PD-L1 antibody or radiation that required systemic steroids
- Toxicity from prior anticancer therapy that has not resolved to Grade <=1
- Evidence of clinically significant active viral, bacterial, or fungal infection within 7 days before the first dose of study treatment requiring systemic or non-topical treatment
- History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
- Participants with prior or concurrent second malignancy cannot be enrolled if prior/concurrent malignancy's natural history of treatment is likely to interfere with any safety or efficacy study endpoints
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: JNJ-95437446
Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. In selected participants in Part 1, amivantamab may also be co-dosed with JNJ-95437446. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1. |
Amivantamab will be administered. JNJ-95437446 will be administered. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants with Adverse Events (AEs) by Severity
기간: Up to 2 years and 4 months
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 2 years and 4 months
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Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
기간: Up to 21 days
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The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation. |
Up to 21 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective Response Rate
기간: Up to 2 years and 4 months
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Objective response rate (ORR) is defined as the percentage of participants who have best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST). |
Up to 2 years and 4 months
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Duration of Response (DOR)
기간: Up to 2 years and 4 months
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DOR is defined for the responders from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST version (v.) 1.1, or death due to any cause, whichever occurs first. |
Up to 2 years and 4 months
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Progression Free Survival (PFS)
기간: Up to 2 years and 4 months
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PFS is defined as the time from the first dose of JNJ-95437446 to either progressive disease (PD) or death due to any cause, whichever comes first. |
Up to 2 years and 4 months
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Maximum Plasma Concentration (Cmax) for JNJ-95437446
기간: Up to 2 years and 4 months
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Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite. |
Up to 2 years and 4 months
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Time to Reach Cmax (Tmax) for JNJ-95437446
기간: Up to 2 years and 4 months
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Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported. |
Up to 2 years and 4 months
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Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-95437446 Antibody-Drug Conjugate, Total Antibody, Released Payload and the Payload's Metabolite
기간: Up to 2 years and 4 months
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AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported. |
Up to 2 years and 4 months
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Number of Participants With Anti JNJ-95437446 Antibodies
기간: Up to 2 years and 4 months
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Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method. |
Up to 2 years and 4 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 95437446LUC1001
- 2025-521535-36-00 (레지스트리 식별자: EUCT number)
- 2025 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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