Um Estudo em Pessoas com Cancro Avançado (Tumores Sólidos) para Testar Diferentes Doses de BI 3810944 e para Descobrir se Ajuda
Um Primeiro-em-Humanos, Fase I, Aberto, Não Randomizado, Ensaio Multicêntrico de Escalada de Dose e Expansão do BI 3810944 em Doentes com Tumores Sólidos e Melanoma
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Boehringer Ingelheim
- Número de telefone: 1-800-243-0127
- E-mail: clintriage.rdg@boehringer-ingelheim.com
Locais de estudo
-
-
-
Brussels, Bélgica, 1200
- Recrutamento
- Cliniques Universitaires Saint-Luc
-
Contato:
- Boehringer Ingelheim
- Número de telefone: 080049616
- E-mail: belgique@bitrialsupport.com
-
Leuven, Bélgica, 3000
- Recrutamento
- UZ Leuven
-
Contato:
- Boehringer Ingelheim
- Número de telefone: 080049616
- E-mail: belgique@bitrialsupport.com
-
-
-
-
Kentucky
-
Louisville, Kentucky, Estados Unidos, 40202
- Recrutamento
- University of Louisville
-
Contato:
- Boehringer Ingelheim
- Número de telefone: 833-602-2368
- E-mail: unitedstates@bitrialsupport.com
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37203
- Recrutamento
- Tennessee Oncology, PLLC - Elliston Place Plaza DDU
-
Contato:
- Boehringer Ingelheim
- Número de telefone: 833-602-2368
- E-mail: unitedstates@bitrialsupport.com
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Ainda não está recrutando
- The University of Texas MD Anderson Cancer Center
-
Contato:
- Boehringer Ingelheim
- Número de telefone: 833-602-2368
- E-mail: unitedstates@bitrialsupport.com
-
-
Virginia
-
Charlottesville, Virginia, Estados Unidos, 22908
- Ainda não está recrutando
- University of Virginia Health System
-
Contato:
- Boehringer Ingelheim
- Número de telefone: 833-602-2368
- E-mail: unitedstates@bitrialsupport.com
-
-
-
-
-
Nijmegen, Holanda, 6525 GA
- Recrutamento
- Radboud Universitair Medisch Centrum
-
Contato:
- Boehringer Ingelheim
- Número de telefone: 08000204613
- E-mail: nederland@bitrialsupport.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
-
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
-
Eastern cooperative oncology group (ECOG) performance status of 0 or 1
-
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)
-
Age ≥18 years
-
Adequate organ function
-
Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator
-
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:
-
Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and/or carcinomatous meningitis
-
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
-
-
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
-
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
-
Prior treatment with organ transplant or allogenic hematopoietic stem-cell transplant
-
Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)
-
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Parte A: Escalada de dose
|
BI 3810944 |
|
Experimental: Parte B: Expansão da dose
|
BI 3810944 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: approximately 2 months
|
approximately 2 months
|
|
|
Part A (dose escalation): Occurrence of DLTs during the primary DLT evaluation period
Prazo: approximately 2 months
|
approximately 2 months
|
|
|
Part B (dose expansion): Objective Response (OR)
Prazo: up to 24 months
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Parte A (escalada de dose): Ocorrência de DLT durante o período de tratamento
Prazo: aproximadamente 2 meses
|
aproximadamente 2 meses
|
|
|
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
Prazo: approximately 2 months
|
Serious Adverse Events (SAEs); Adverse Event of Special Interest (AESIs). |
approximately 2 months
|
|
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
Prazo: up to 24 months
|
up to 24 months
|
|
|
Part B (dose expansion): Duration of Response (DoR)
Prazo: up to 24 months
|
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
|
|
Part B (dose expansion): Disease Control (DC)
Prazo: up to 24 months
|
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
|
|
Part B (dose expansion): Progression-Free Survival (PFS)
Prazo: up to 24 months
|
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
|
|
Part A (dose escalation) and Part B (dose expansion): Maximum measured concentration of analytes in serum (Cmax)
Prazo: up to 24 months
|
up to 24 months
|
|
|
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)
Prazo: up to 24 months
|
up to 24 months
|
|
|
Part A (dose escalation) and Part B (dose expansion): Terminal half-life of analytes (t1/2)
Prazo: up to 24 months
|
up to 24 months
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1527-0001
- U1111-1323-2127 (Identificador de registro: WHO International Clinical Trials Registry Platform (ICTRP))
- 2025-522045-21-00 (Identificador de registro: CTIS)
- 2025 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .