진행성 암(고형 종양) 환자를 대상으로 BI 3810944의 다양한 용량을 시험하고 효과 여부를 확인하는 연구
고형 종양 및 흑색종 환자를 대상으로 BI 3810944의 1상, 개방형, 비무작위, 다기관 용량 증량 및 확장 임상시험(최초 인체 적용)
This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer.
Participants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment. The treatment duration is planned for 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects.
The doctors also regularly check the size of the tumour with imaging methods.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Boehringer Ingelheim
- 전화번호: 1-800-243-0127
- 이메일: clintriage.rdg@boehringer-ingelheim.com
연구 장소
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Nijmegen, 네덜란드, 6525 GA
- 모병
- Radboud Universitair Medisch Centrum
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연락하다:
- Boehringer Ingelheim
- 전화번호: 08000204613
- 이메일: nederland@bitrialsupport.com
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Kentucky
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Louisville, Kentucky, 미국, 40202
- 모병
- University of Louisville
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연락하다:
- Boehringer Ingelheim
- 전화번호: 833-602-2368
- 이메일: unitedstates@bitrialsupport.com
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Tennessee
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Nashville, Tennessee, 미국, 37203
- 모병
- Tennessee Oncology, PLLC - Elliston Place Plaza DDU
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연락하다:
- Boehringer Ingelheim
- 전화번호: 833-602-2368
- 이메일: unitedstates@bitrialsupport.com
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Texas
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Houston, Texas, 미국, 77030
- 아직 모집하지 않음
- The University of Texas MD Anderson Cancer Center
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연락하다:
- Boehringer Ingelheim
- 전화번호: 833-602-2368
- 이메일: unitedstates@bitrialsupport.com
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Virginia
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Charlottesville, Virginia, 미국, 22908
- 아직 모집하지 않음
- University of Virginia Health System
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연락하다:
- Boehringer Ingelheim
- 전화번호: 833-602-2368
- 이메일: unitedstates@bitrialsupport.com
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Brussels, 벨기에, 1200
- 모병
- Cliniques Universitaires Saint-Luc
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연락하다:
- Boehringer Ingelheim
- 전화번호: 080049616
- 이메일: belgique@bitrialsupport.com
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Leuven, 벨기에, 3000
- 모병
- UZ Leuven
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연락하다:
- Boehringer Ingelheim
- 전화번호: 080049616
- 이메일: belgique@bitrialsupport.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Trial participant population specifically to Part A and B:
- Part A only: participants with any histologically or cytologically confirmed diagnosis of solid tumour who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Participant must have exhausted available treatment options known to prolong survival for their disease.
- Part B only: participants with histologically or cytologically confirmed diagnosis of who has progressed on, or is intolerant to available standard therapies, or for whom no standard therapy with proven benefit exists according to the local and institutional guidelines. Participants should not have received >3 previous lines of treatment (excluding prior systemic regimens received at adjuvant or neoadjuvant setting and excluding treatment with tumour-infiltrating lymphocytes at any timepoint). B-raf protein kinase (BRAF) mutation status must be known prior to screening
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Eastern cooperative oncology group (ECOG) performance status of 0 or 1
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Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours (RECIST v 1.1)
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Age ≥18 years
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Adequate organ function
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Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator
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All toxicities related to previous anticancer therapies have resolved to common terminology criteria for adverse events (CTCAE) Grade ≤1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be CTCAE Grade ≤2 and amenorrhea/menstrual disorders which can be any Grade) Further inclusion criteria apply.
Exclusion Criteria:
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Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and/or carcinomatous meningitis
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Participants with asymptomatic (i.e. no clinical neurological symptoms) brain lesions are eligible provided they meet the following criteria:
- Radiotherapy or surgery for brain metastases was completed ≥2 weeks before the first administration of BI 3810944
- Patient is off steroids for ≥7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for ≥7 days or on stable doses of anti-epileptic drugs for malignant CNS disease
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A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the step-up dose of BI 3810944
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Prior anticancer therapy:
- Participants who have been treated with any other anticancer drug(s), within 28 days or within 5 half-life periods (whichever is shorter) prior to the first administration of BI 3810944
- Participants who have been treated with extensive field radiotherapy including whole brain irradiation, within 2 weeks prior to first administration of BI 3810944
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Prior treatment with organ transplant or allogenic hematopoietic stem-cell transplant
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Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)
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Women who are pregnant, breastfeeding or who plan to become pregnant or breastfeeding during the trial or within 4 months after the last dose of BI 3810944 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)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 파트 A: 용량 증량
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BI 3810944 |
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실험적: 파트 B: 용량 확장
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BI 3810944 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the primary Dose Limiting Toxicity (DLT) evaluation period, as a sign of minimal immunological activity that primes the immune system
기간: approximately 2 months
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approximately 2 months
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Part A (dose escalation): Occurrence of DLTs during the primary DLT evaluation period
기간: approximately 2 months
|
approximately 2 months
|
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Part B (dose expansion): Objective Response (OR)
기간: up to 24 months
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OR, defined as best overall response of confirmed CR and/or confirmed PR, where best overall response is determined according to RECIST v 1.1 assessed from first treatment administration until the earliest event of PD, death or last evaluable tumour assessment during the on-treatment period before start of subsequent anticancer therapy, loss to follow up, withdrawal of consent, or end of trial. |
up to 24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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파트 A (용량 증량): 치료 기간 중 DLT 발생률
기간: 약 2개월
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약 2개월
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Part A (dose escalation): Occurrence of Adverse Events (AEs) (including SAEs, drug-related AEs, AESIs, and AEs leading to discontinuation of trial drug) during the on-treatment period
기간: approximately 2 months
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Serious Adverse Events (SAEs); Adverse Event of Special Interest (AESIs). |
approximately 2 months
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Part B (dose expansion): Occurrence of AEs (including SAEs, drug-related AEs, AESIs, and AEs leading to discontinuation of trial drug) during the on-treatment period
기간: up to 24 months
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up to 24 months
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Part B (dose expansion): Duration of Response (DoR)
기간: up to 24 months
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DoR, defined as the time from first documented Complete Response (CR) or Partial Response (PR) until the earliest of Progressive Disease (PD) or death among trial participants with OR according to RECIST v 1.1. |
up to 24 months
|
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Part B (dose expansion): Disease Control (DC)
기간: up to 24 months
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DC, defined as best overall response of confirmed CR, or confirmed PR, or Stable Disease (SD) where best overall response is defined according to RECIST v 1.1 from first treatment administration until the earliest of PD, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up, withdrawal of consent, or end of trial. |
up to 24 months
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Part B (dose expansion): Progression-Free Survival (PFS)
기간: up to 24 months
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PFS, defined as the time from first administration until tumour progression according to RECIST v 1.1 or death from any cause, whichever occurs earlier. |
up to 24 months
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Part A (dose escalation) and Part B (dose expansion): Maximum measured concentration of analytes in serum (Cmax)
기간: up to 24 months
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up to 24 months
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Part A (dose escalation) and Part B (dose expansion): Area under the serum concentration-time curve over the time interval from 0 to the last measured time point, tz (AUC0-tz)
기간: up to 24 months
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up to 24 months
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Part A (dose escalation) and Part B (dose expansion): Terminal half-life of analytes (t1/2)
기간: up to 24 months
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up to 24 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
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
- 1527-0001
- U1111-1323-2127 (레지스트리 식별자: WHO International Clinical Trials Registry Platform (ICTRP))
- 2025-522045-21-00 (레지스트리 식별자: CTIS)
- 2025 (미국 NIH 보조금/계약)
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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