A Study to Test Different Doses of BI 3968621 When Given Alone or With Ezabenlimab in Patients With Advanced Cancer
Advanced Solid Tumour
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- 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
- 90 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
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 advanced cancer that cannot be removed by surgery or have spread to other parts of the body. The purpose of this study is to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab. Another purpose is to find out if taking these medicines can stop tumours from growing or make tumours shrink. In this study, BI 3968621 is given to people for the first time.
The study is done in 3 parts. The parts are called Part A, Part A2, and Part B. Participants get BI 3968621 alone or in combination with ezabenlimab depending on which part they are in. Part A is done to find the highest and the most suitable dose of BI 3968621 that people with advanced cancer can tolerate. Part A2 is done to find out if taking BI 3968621, at certain dose levels, can stop or slow down tumour growth in participants with kidney cancer. Part B is done to find out how BI 3968621 is tolerated when given with ezabenlimab. BI 3968621 is taken daily as tablets. Ezabenlimab is given as an infusion into a vein once every 3 weeks.
Participants can receive study treatment for up to 2 years if they benefit and can tolerate it. During this time, they visit the study site regularly. The number of visits depends on how participants respond to and tolerate the study treatment. Researchers look at the number of participants with certain severe health problems that happen within 3 weeks after the first study treatment. The study doctors check participants' health, take note of unwanted effects, take blood samples, and check how the cancer responds to 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:
- Male and female participants ≥18 years of age and at least at the legal age of consent
- Patients with a histologically confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type). Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted approved treatment options known to prolong survival for their disease
- At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥3 months at the start of treatment in the opinion of the investigator
- Patients with known brain metastases are eligible, provided they meet the protocol-defined criteria
- Patients must have adequate organ function based on haematological, hepatic, renal, and coagulation parameters Further inclusion criteria apply.
Exclusion Criteria:
- Previous or concomitant malignancies other than the one treated in this trial within the past 3 years (except effectively treated malignancy considered cured by local treatment, e.g. non melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ)
- Patient with known leptomeningeal disease or spinal cord compression due to disease
- Patients with hepatitis C infection or active hepatitis B infection (chronic or acute)
- Patients with known history of Human immunodeficiency virus (HIV) infection who meet protocol-defined criteria
- Patient with active autoimmune disease or a documented history of autoimmune disease, which requires systemic treatment (e.g. corticosteroids or immunosuppressive drugs)
- Patient with a diagnosis of immunodeficiency other than HIV
- Manifestation of malabsorption or any other condition that could affect oral absorption, distribution or metabolism of the study drug Further exclusion criteria apply.
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
BI 3968621 dose escalation monotherapy (Part A)
No informado en este registro.
Drug: BI 3968621
BI 3968621 dose expansion monotherapy (Part A2)
No informado en este registro.
Drug: BI 3968621
BI 3968621 + ezabenlimab dose escalation combination therapy (Part B)
No informado en este registro.
Drug: BI 3968621 · Drug: ezabenlimab
BI 3968621 DRUG
BI 3968621
ezabenlimab DRUG
ezabenlimab
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Occurrence of dose-limiting toxicities (DLTs) during the primary DLT evaluation period (Dose escalation part A and B)
Plazo: During the first treatment cycle, up to 21 days
No informado en este registro.
Objective response (OR)
Plazo: Up to 2 years
defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (Part A2)
Medidas secundarias
Occurrence of treatment-emergent adverse events (AEs)
Plazo: Up to 2 years
No informado en este registro.
Occurrence of dose-limiting toxicities (DLTs)
Plazo: Up to 2 years
No informado en este registro.
Occurrence of drug-related AEs
Plazo: Up to 2 years
No informado en este registro.
Occurrence of treatment-emergent serious adverse events (SAEs)
Plazo: Up to 2 years
No informado en este registro.
Objective response (OR)
Plazo: Up to 2 years
defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (part A + B)
Duration of response (DoR)
Plazo: Up to 2 years
based on RECIST v1.1, defined as the time from first confirmed CR or PR until the earliest of progressive disease (PD) or death among patients with an OR (part A2)
Progression-free survival (PFS)
Plazo: Up to 2 years
defined as the time from first treatment administration until tumour progression according to RECIST v1.1 or death from any cause, whichever occurs first (part A2)
Progression-free survival (PFS) at 6 months (PFS6)
Plazo: At 6 months
defined as being alive and without tumour progression at 6 months from first treatment administration (part A2)
Clinical Benefit (CB)
Plazo: Up to 2 years
defined as achievement of BOR of CR or PR of any duration, or stable disease (SD) of at least 6 months according to RECIST v1.1 (part A2)
Disease control (DC)
Plazo: Up to 2 years
based on RECIST v1.1, defined as the best overall response of CR, PR, or SD from the first administration of trial medication until the earliest of PD, death, last evaluable tumour assessment before the start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first
Immune objective response (iOR)
Plazo: Up to 2 years
as determined by investigator's assessment according to iRECIST, defined as immune BOR (iBOR) of immune CR (iCR) or immune PR (iPR), determined from date of first administration until earliest of disease progression (immune unconfirmed progressive disease \[iUPD\] that is confirmed at next radiological assessment), death, last evaluable tumour assessment before start subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first
Immune DC (iDC)
Plazo: Up to 2 years
based on iRECIST v1.1, defined as the best overall response of iCR, iPR or iSD from the first administration of trial medication until the earliest of iUPD (provided that iCPD is the next time point response, i.e. progression is confirmed at the next tumour assessment), death, last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up, or withdrawal of consent, whichever occurs first
Maximum measured concentration of the analyte in plasma (after the first dose in Cycle 1) (Cmax)
Plazo: Up to Day 15 in cycle 1 (each cycle is 21 days)
No informado en este registro.
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose in Cycle 1 (AUCτ,1)
Plazo: Up to Day 15 in cycle 1 (each cycle is 21 days)
No informado en este registro.
Maximum measured concentration of the analyte in plasma at steady state (after the first dose in Cycle 2) (Cmax,ss)
Plazo: Up to Day 15 in cycle 2 (each cycle is 21 days)
No informado en este registro.
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (after the first dose in Cycle 2) (AUCτ,ss)
Plazo: Up to Day 15 in cycle 2 (each cycle is 21 days)
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (10)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
10 centros
Florida Cancer Specialists-Sarasota-61670Sarasota, Florida, United StatesReclutando
Emory UniversityAtlanta, Georgia, United StatesAún no recluta
Thomas Jefferson UniversityPhiladelphia, Pennsylvania, United StatesAún no recluta
Sarah Cannon Research Institute-Nashville-48456Nashville, Tennessee, United StatesReclutando
The University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesAún no recluta
Universitair Ziekenhuis GentGhent, BelgiumAún no recluta
Institut Gustave RoussyVillejuif, FranceAún no recluta
Japanese Foundation for Cancer ResearchTokyo, Koto-ku, JapanReclutando
Hospital Universitari Vall d'HebronBarcelona, SpainAún no recluta
Hospital Clinico De Valencia (INCLIVA)Valencia, SpainAún no recluta
Equipo y fechas
- Patrocinador principal
- Boehringer Ingelheim
- Inicio del estudio
- 10 nov 2026 Estimado
- Finalización primaria
- 3 sept 2030 Estimado
- Finalización del estudio
- 3 sept 2030 Estimado
- Primera publicación
- 1 oct 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A First-in-human, Multicentre, Phase Ia Dose Escalation Study of BI 3968621 as Monotherapy and in Combination With Ezabenlimab to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumour Activity in Patients With Advanced Solid Tumours
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026