SuspendidoNCT05155332Registro de ClinicalTrials.gov

A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)

Solid Tumors

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: Fase 1
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 190 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Por qué se detuvo el estudio

Sponsor decision - temporary enrolment hold as a precautionary measure following a safety event.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Sin asignación al azar
Enmascaramiento: Sin enmascaramiento

Part 1 (Monotherapy): Arm A

No informado en este registro.

Drug: BI 1831169

Part 1 (Monotherapy): Arm B

No informado en este registro.

Drug: BI 1831169

Part 1 (Monotherapy): Arm C

No informado en este registro.

Drug: BI 1831169

Part 2 (Combination therapy): Arm D

No informado en este registro.

Drug: BI 1831169 · Drug: anti-PD-1 antibody

Part 2 (Combination therapy): Arm E

No informado en este registro.

Drug: BI 1831169 · Drug: anti-PD-1 antibody

BI 1831169 DRUG

BI 1831169

anti-PD-1 antibody DRUG

anti-PD-1 antibody

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period

Plazo: up to 21 days

Part 1 (Monotherapy).

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)

Plazo: up to 49 months

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.

Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period

Plazo: up to 21 days

Part 2 (Combination Therapy).

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)

Plazo: up to 49 months

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).

Medidas secundarias

Part 1.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period

Plazo: up to 49 months

No informado en este registro.

Part 1.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period

Plazo: up to 49 months

No informado en este registro.

Part 1.2, Dose expansion: Occurrence of adverse events during the on-treatment period

Plazo: up to 49 months

No informado en este registro.

Part 1.2, Dose expansion: Occurrence of DLTs during the mono MTD evaluation period

Plazo: up to 49 months

No informado en este registro.

Part 2.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period

Plazo: up to 49 months

No informado en este registro.

Part 2.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period

Plazo: up to 49 months

No informado en este registro.

Part 2.2 - Dose Expansion by Indication, All Arms: Occurrence of adverse events during the on-treatment period

Plazo: up to 49 months

No informado en este registro.

Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)

Plazo: up to 49 months

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.

Part 2.2, Dose Expansion by Indication, Arms D and E: Disease control (DC)

Plazo: up to 49 months

DC is defined as a BOR of iCR, iPR or immunotherapy stable disease (iSD), with BOR defined according to iRECIST by Investigator's assessment.

Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months (PFS-4)

Plazo: up to 4 months

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.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (34)

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Buscar un centro en este estudio

34 centros

Banner MD Anderson Cancer Center-Gilbert-55251Gilbert, Arizona, United StatesEstado desconocido

De qué trata este estudio

Acerca de la investigación

¿Quién podría participar?

Tratamiento, grupos y participación

Qué evalúan los investigadores

Medidas principales

Medidas secundarias

Centros de investigación (34)

Equipo y fechas

Contactos oficiales del estudio

Consulta a Wellness Clinical Research