Activo, sin reclutamientoNCT04958239Registro de ClinicalTrials.gov

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer

Neoplasms

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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: 151 Real

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 (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer.

In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein.

BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time.

Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note 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:

All cohorts:

Patients with locally advanced, unresectable or metastatic solid tumors who are either refractory after standard therapy for the disease or for whom standard therapy is not appropriate
Tumor with expected high expression of Fibroblast activation protein (FAP) of the following histologies:

Non-small cell lung carcinoma (NSCLC)
Gastric cancer
Esophageal adenocarcinoma or squamous cell carcinoma
Urothelial bladder carcinoma
Head and neck squamous cell carcinoma
Cutaneous malignant melanoma
Cutaneous squamous cell carcinoma
Hepatocellular carcinoma
Pancreatic adenocarcinoma
Colorectal cancer
Malignant pleural mesothelioma
Cervical squamous cell cancer
Ovarian carcinoma
Triple-negative breast cancer
At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years
Signed and dated, written informed consent (IC) in accordance with ICH-GCP and local legislation prior to admission to the trial
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
Adequate liver, bone marrow and renal organ function
Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. These methods must be used during the study and for at least 6 months after the last dose of the study medication. A list of contraception methods meeting these criteria is provided in the patient information.
Patients with brain metastases are eligible provided they meet all of the following criteria:

Brain metastases have adequately been treated and are considered stable by the Investigator
Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 765179
Patient is off steroids for at least 7 days (physiologic doses of steroids is permitted, if this was stable for the last 4 weeks)
The patient is off anti-epileptic drugs for at least 7 days

Back-fill cohorts only:

Patient has agreed to and signed an IC form to provide mandatory pre-treatment and on-treatment fresh tumor biopsy
At least one lesion (separate from the evaluable target lesion outside of the CNS as defined per RECIST v1.1) that is accessible for mandatory paired pre and on-treatment biopsy

Phase 1b:

Histologically or cytologically confirmed diagnosis of metastatic or incurable, recurrent head and neck squamous cell carcinoma (HNSCC)
No prior systemic therapy administered in the metastatic or incurable, recurrent setting
Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years
Signed and dated written IC in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply

Exclusion Criteria:

Phase 1a

Currently enrolled in another investigational device or drug trial
Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:

Effectively treated non-melanoma skin cancers
Effectively treated carcinoma in situ of the cervix
Effectively treated ductal carcinoma in situ
Other effectively treated malignancy that is considered cured by 'local treatment'
Previous treatment with agents targeting CD137
Known leptomeningeal disease or spinal cord compression due to disease
Anticoagulant treatment that cannot be safely interrupted if medically needed (e.g., biopsy) based on the opinion of the Investigator
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)
Patient has a diagnosis of immunodeficiency
Patient with history of immunosuppressive medication within 14 days prior to the first dose of BI 765179. The following are exceptions to this criterion:

Use of intranasal, inhaled, or topical corticosteroids, local steroid injections (e.g., intra-articular injections)
Systemic corticosteroids at physiologic doses ≤10 mg/day (prednisone or equivalent)
Physiological replacement dose of corticosteroids Further exclusion criteria apply.

Phase Ib

Disease suitable for local therapy administered with curative intent
Participants must not have a primary tumor site of nasopharynx or sino-nasal cancer or salivary gland cancers (any histology)
Currently enrolled in another investigational device or drug trial
Life expectancy of \<3 months and/or has rapidly progressing disease
Diagnosed and/or treated additional malignancy within 2 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or in situ breast cancers 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

Phase 1 Arm A: BI 765179

No informado en este registro.

Drug: BI 765179

Phase 1a Arm B: BI 765179 + ezabenlimab

No informado en este registro.

Drug: BI 765179 · Drug: Ezabenlimab

Phase 1b Cohort 1: pembrolizumab + low dose of BI 765179

No informado en este registro.

Drug: BI 765179 · Drug: Pembrolizumab

Phase 1b Cohort 2: pembrolizumab + high dose of BI 765179

No informado en este registro.

Drug: BI 765179 · Drug: Pembrolizumab

BI 765179 DRUG

BI 765179

Ezabenlimab DRUG

Ezabenlimab

Pembrolizumab DRUG

Pembrolizumab

Prepara tus preguntas

Qué evalúan los investigadores

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

Medidas principales

Phase 1a: Maximum Tolerated Dose (MTD)

Plazo: Up to Day 21 (end of Cycle 1)

MTD is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period. The MTD will be assessed based on the number of patients experiencing DLTs, graded according to Common terminology criteria for adverse events (CTCAE) version 5.0, during the MTD evaluation period.

Phase 1a: Occurrence of Dose Limiting Toxicities (DLTs) in the MTD evaluation period

Plazo: Up to Day 21 (end of Cycle 1)

No informado en este registro.

Phase 1b: Objective response (OR)

Plazo: Up to 2 years.

OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response evaluation criteria in solid tumors (RECIST) version (v) 1.1 by Investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

Medidas secundarias

Phase 1a: Occurrence of DLTs during the on-treatment period (per arm)

Plazo: up to 36 months

No informado en este registro.

Phase 1a: Maximum measured concentration of BI 765179 in plasma (Cmax)

Plazo: Up to Day 21 (end of Cycle 1)

No informado en este registro.

Phase 1a: Area under the concentration-time curve of BI 765179 in plasma over a uniform dosing interval from zero to 504h (AUC0-504)

Plazo: Up to Day 21 (end of Cycle 1)

No informado en este registro.

Phase Ib: Occurrence of adverse events (AEs) using the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5

Plazo: Up to 2 years.

No informado en este registro.

Phase 1b: Occurrence of serious AEs (SAEs) during the on-treatment period

Plazo: Up to 2 years.

No informado en este registro.

Phase 1b: OR assessed by the Investigator according to immune-related RECIST (iRECIST)

Plazo: Up to 2 years.

OR assessed by the Investigator according to immuno-related RECIST (iRECIST) is defined as best overall response of immune-related complete response (iCR) and immune related partial response (iPR), where the best overall response is the best time point response recorded from the first administration of study medication until the end of treatment.

Phase Ib: Duration of response (DoR) assessed by RECIST v1.1

Plazo: Up to 2 years.

DoR assessed by RECIST v1.1 is defined as the time from first documented CR or PR until the earliest of PD or death among patients with an OR.

Phase 1b: DoR assessed by iRECIST

Plazo: Up to 2 years.

DoR assessed by iRECIST is defined as the time from first documented iCR or iPR until the earliest of unconfirmed progression of disease (iUPD) or death among patients with an OR (iCR, iPR).

Phase 1b: Progression-free survival (PFS) in all patients assessed by the Investigator according to RECIST v1.1

Plazo: Up to 2 years.

PFS in all patients assessed by the Investigator according to RECIST v1.1 is defined as the time from first treatment administration until tumor progression or death from any cause, whichever occurs earlier.

Phase 1b: PFS in all patients assessed by the Investigator according to iRECIST

Plazo: Up to 2 years.

PFS in all patients assessed by the Investigator according to iRECIST is defined as the time from first administration of study medication until the first date of iUPD (provided that confirmed progressive disease (iCPD) is the next time point response, i.e., progression is confirmed at the next tumor assessment) or death from any cause, whichever occurs earlier.

Phase 1b: PFS rate at 14 weeks

Plazo: Up to 2 years.

PFS rate at 14 weeks is defined as the proportion of patients who survive and are progression free at least 14 weeks after the date of first treatment.

Phase 1b: Overall survival (OS)

Plazo: Up to 2 years.

OS is defined as the time from first treatment administration until death from any cause.

Phase 1b: OS rate at 12 months

Plazo: Up to 2 years.

OS rate at 12 months is defined as the proportion of patients with OS ≥12 months after the date of first treatment.

El registro no indica resultados publicados.

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

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Centros de investigación (48)

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48 centros

University of ArizonaTucson, 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 (48)

Equipo y fechas

Contactos oficiales del estudio

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