다양한 유형의 진행성 암(고형 종양) 환자를 대상으로 BI 1831169 단독 및 에자벤리맙과의 병용 용량을 테스트하기 위한 연구
진행성 또는 전이성 고형 종양 환자를 대상으로 BI 1831169 단독 요법 및 에자벤리맙 병용 요법의 I상 공개 라벨, 용량 증량 시험
This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time.
This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle.
Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
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Tübingen, 독일, 72076
- Universitätsklinikum Tübingen
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Ulm, 독일, 89081
- Universitätsklinikum Ulm
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Arizona
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Gilbert, Arizona, 미국, 85234
- Banner MD Anderson Cancer Center-Gilbert-55251
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Tucson, Arizona, 미국, 85719
- University of Arizona
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California
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La Jolla, California, 미국, 92037
- University of California San Diego
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Santa Monica, California, 미국, 90404
- Providence St. John's Health Center
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Denver
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Florida
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Miami, Florida, 미국, 33136
- University of Miami
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Orlando, Florida, 미국, 32806
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Winship Cancer Institute
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Kentucky
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Louisville, Kentucky, 미국, 40202
- University of Louisville
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- M Health Fairview University of Minnesota Medical Center
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New Jersey
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Morristown, New Jersey, 미국, 07960
- Morristown Medical Center
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, 미국, 29605
- Prisma Health
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Tennessee
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology, PLLC - Elliston Place Plaza DDU
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Texas
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Houston, Texas, 미국, 77030
- The University of Texas MD Anderson Cancer Center
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Edegem, 벨기에, 2650
- Universitair Ziekenhuis Antwerpen
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Leuven, 벨기에, 3000
- UZ Leuven
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Geneva, 스위스, 1205
- University Hospital Geneva
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L'Hospitalet de Llobregat, 스페인, 08907
- Hospital Duran i Reynals
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Madrid, 스페인, 28040
- Fundación Jiménez Díaz
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Pamplona, 스페인, 31008
- Clínica Universidad de Navarra
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Innsbruck, 오스트리아, 6020
- Medical University of Innsbruck
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Salzburg, 오스트리아, 5020
- Salzburg Cancer Research Institute
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Milan, 이탈리아, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Ontario
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Cancer Centre
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Bordeaux, 프랑스, 33000
- INS Bergonie
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Marseille, 프랑스, 13385
- HOP Timone
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Rennes, 프랑스, 35042
- CTR Eugène Marquis
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Villejuif, 프랑스, 94805
- Institut Gustave Roussy
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South Australia
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Bedford Park, South Australia, 호주, 5062
- Southern Oncology Clinical Research Unit
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Victoria
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Frankston, Victoria, 호주, 3199
- Peninsula Haematology & Oncology
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors
- At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of BI 1831169
- Has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2.
Further inclusion criteria apply.
Exclusion Criteria:
- Previous treatment with Vesicular stomatitis virus (VSV)-based agents
- Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
- Presence of brain metastases
- Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
- Chronic steroid use, regardless of daily dose Further exclusion criteria apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 파트 1(단일요법): A군
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BI 1831169 |
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실험적: 파트 1(단일요법): Arm B
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BI 1831169 |
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실험적: 파트 1(단일요법): Arm C
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BI 1831169 |
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실험적: 파트 2(병용 요법): Arm D
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BI 1831169 anti-PD-1 antibody |
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실험적: 파트 2(병용 요법): Arm E
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BI 1831169 anti-PD-1 antibody |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
기간: up to 21 days
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Part 1 (Monotherapy). |
up to 21 days
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Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)
기간: up to 49 months
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BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. |
up to 49 months
|
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Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period
기간: up to 21 days
|
Part 2 (Combination Therapy). |
up to 21 days
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|
Part 2.2, Dose Expansion: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed partial response (iPR)
기간: up to 49 months
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BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST) by Investigator's assessment. BOR will consider all tumor assessments from first administration of trial medication until disease progression, death, last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent (whichever occurs first). |
up to 49 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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파트 1.1, 용량 증량/확인: 치료 기간 중 DLT 발생
기간: 최대 49개월
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최대 49개월
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파트 1.1, 용량 증량/확인: 치료 기간 중 이상반응 발생
기간: 최대 49개월
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최대 49개월
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1.2부, 용량 확장: 치료 기간 중 이상반응 발생
기간: 최대 49개월
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최대 49개월
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1.2부, 용량 확장: 단일 MTD 평가 기간 동안 DLT 발생
기간: 최대 49개월
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최대 49개월
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파트 2.1, 용량 증량/확인: 치료 기간 중 DLT 발생
기간: 최대 49개월
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최대 49개월
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파트 2.1, 용량 증량/확인: 치료 기간 중 이상반응 발생
기간: 최대 49개월
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최대 49개월
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파트 2.2 - 적응증에 따른 용량 확장, 모든 군: 치료 기간 동안 부작용 발생
기간: 최대 49개월
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최대 49개월
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Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)
기간: up to 49 months
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DoR is defined as the time from first documented iCR or iPR according to iRECIST until the earliest of disease progression by Investigator's assessment or death among patients with OR. |
up to 49 months
|
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Part 2.2, Dose Expansion by Indication, Arms D and E: Disease control (DC)
기간: up to 49 months
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DC is defined as a BOR of iCR, iPR or immunotherapy stable disease (iSD), with BOR defined according to iRECIST by Investigator's assessment. |
up to 49 months
|
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Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months (PFS-4)
기간: up to 4 months
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PFS-4 is defined as the proportion of patients who are alive and without progression by 4 months from the start of treatment. PFS is assessed by the Investigator using iRECIST. |
up to 4 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 1456-0001
- 2020-003902-30 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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