델타 유사 리간드 3(DLL3)에 대해 양성인 소세포폐암 및 기타 신경내분비종양 환자에서 다양한 용량의 BI 764532를 테스트하기 위한 연구.
DLL3을 발현하는 소세포 폐암종 및 기타 신경내분비 신생물 환자를 대상으로 반복 정맥 주입으로 관리되는 BI 764532의 최초 인간 1상, 비무작위, 공개 라벨, 다기관 용량 증량 시험
This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.
The purpose of this study is to find out the highest dose of obrixtamig and the best treatment schedule that people can tolerate. Obrixtamig is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, obrixtamig is given to people for the first time. Interim clinical data are available for obrixtamig.
Participants get obrixtamig either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Cologne, 독일, 50937
- Universitätsklinikum Köln (AöR)
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Dresden, 독일, 01307
- Technische Universität Dresden
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Würzburg, 독일, 97078
- Universitätsklinikum Würzburg AÖR
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Georgia
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Atlanta, Georgia, 미국, 30322
- Winship Cancer Institute
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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland School of Medicine
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Missouri
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St Louis, Missouri, 미국, 63108
- Washington University School of Medicine
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15232
- University of Pittsburgh Medical Center
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Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, 스페인, 08003
- Hospital del Mar
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Pamplona, 스페인, 31008
- Clínica Universidad de Navarra
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Valencia, 스페인, 46010
- Hospital Clinico Universitario de Valencia
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Chiba, Kashiwa, 일본, 277-8577
- National Cancer Center Hospital East
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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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Signed and dated, written informed consent form (ICF2, ICF3 or ICF4) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
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Locally advanced or metastatic cancer not amenable to curative treatment; of following histologies:
- Small cell lung carcinoma (SCLC)
- Large cells neuroendocrine lung carcinoma (LCNEC)
- Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
- Tumours must be positive for DLL3 expression (on archived tissue or instudy fresh biopsy) according to central pathology review in order to start obrixtamig
- Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumor cells component is predominant and represent at least 50% of the overall tumour tissue.
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For back-fill cohorts only: patient has agreed to and signed an IC to provide mandatory pre-treatment and on-treatment fresh tumor biopsy.
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Patient has failed or is not eligible for available standard therapies according to local guidelines. Standard therapies should include at least one line of chemotherapy that should include platinum for patients with small cells carcinoma tumors histologies.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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At least one evaluable lesion outside of CNS as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
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Subjects with brain metastases are eligible provided they meet the following criteria:
- Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of obrixtamig
- Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant Central Nervous System (CNS) disease.
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Adequate liver, bone marrow and renal organ function. Further inclusion criteria apply.
Exclusion Criteria:
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Previous treatment with T cell Engager (TcE) or cell therapies targeting DLL3. Other DLL3 targeting agents (like Rovalpituzumab tesirine (RovaT)) are allowed only if DLL3 positivity is documented after completion of treatment with DLL3 targeting agent in post-treatment biopsy.
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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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Persistent toxicity from previous treatments that has not resolved to = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy).
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Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of obrixtamig. Physiological replacement of steroids is allowed.
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Prior anti-cancer therapy:
- Patients who have been treated with any other anti-cancer drug within 3 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of obrixtamig.
- Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of obrixtamig.
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Other active malignancy that could interfere with the prognosis and treatment of the disease of the study.
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Major surgery within 28 days of first dose obrixtamig.
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Women who are pregnant (including those who are considered to be possibly pregnant based on the investigator's clinical judgement), nursing/breast feeding or who plan to become pregnant or nurse while in the trial or within 60 days after the last dose of study treatment.
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Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to first dose of trial medication. Patients who have any clinical signs of infection within 48 h prior to first dose of trial medication are not eligible.
Further exclusion criteria apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Arm 1: Obrixtamig
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Obrixtamig - parenteral 1
다른 이름들:
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실험적: Arm 2: Obrixtamig
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Obrixtamig - parenteral 2
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Arm 1 및 Arm 2: MTD 평가 기간 동안 DLT 환자 수
기간: 최대 36개월
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최대 36개월
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Arm 1 and Arm 2: Maximum tolerated dose (MTD)
기간: up to 36 months
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Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. Separate MTDs will be determined for each Regimen. |
up to 36 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Arm 1 및 Arm 2: 균일한 투여 간격 τ에 대한 분석물질의 농도-시간 곡선(AUCτ) 아래 영역
기간: 최대 36개월
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최대 36개월
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Arm 1 and Arm 2: Maximum measured concentration (Cmax) of obrixtamig
기간: up to 36 months
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up to 36 months
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Arm 1 and Arm 2: Objective response based on RECIST 1.1 criteria in patients with measurable disease
기간: up to 36 months
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Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with measurable disease |
up to 36 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 (실제)
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
기타 연구 ID 번호
- 1438-0001
- 2019-000729-31 (레지스트리 식별자: EudraCT Number)
- 2024-513100-34-00 (레지스트리 식별자: CTIS)
- 2019 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD 공유 기간
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
IPD 공유 액세스 기준
For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .