A Study to Test How Well Different Doses of BI 3822971 Are Tolerated by People With Advanced Cancer (Solid Tumours)

Официальное название

A First-in-human, Open-label, Phase I Trial to Determine the Safety and Tolerability of BI 3822971 in Patients With Unresectable Advanced or Metastatic Solid Cancers

Обзор

This study is open to adults with advanced or metastatic solid cancer, such as non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, esophageal squamous cell carcinoma, bladder cancer, vulvar cancer, and cervical cancer. People can join the study if they have no remaining standard treatment options and have a measurable lesion outside the central nervous system. The purpose of this study is to find out how well a medicine called BI 3822971 is tolerated in people with these cancers. Researchers also want to find a dose and dosing schedule of BI 3822971 that is safe and is well tolerated. In this study, BI 3822971 is given to humans for the first time. BI 3822971 is being developed to help the immune system fight cancer. This schedule can change during the course of the trial depending on the data generated. All participants receive the study medicine (there is no randomization and no placebo group). Participants visit the study site and may need to stay overnight for observation, especially on days when the medicine is administered. Participants can stay in the study for up to 3 years as long as they benefit from treatment and can tolerate it. During this time, doctors regularly check the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects. They collect information on any health problems of the participants and take blood samples.

Вмешательства

• Препарат BI 3822971
  BI 3822971

Первичные конечные точки

• Occurrence of treatment-emergent adverse events (AEs) [Срок оценки: up to 36 months]
• Occurrence of dose limiting toxicities (DLTs) [Срок оценки: up to 36 months]

Вторичные конечные точки (2)

• Maximum measured concentration (Cmax) of BI 3822971 in plasma [Срок оценки: up to 36 months]
• Area under the concentration-time curve (AUC) of BI 3822971 in plasma [Срок оценки: up to 36 months]

Критерии участия

Критерии включения

• Patients must have histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), esophageal squamous cell cancer (ESCC), bladder cancer (BC), vulvar cancer (VC) and cervical cancer (CC) and have no remaining standard treatment options (including those who have failed or are intolerant to standard therapy).
• Patients ≥18 years of age and over the legal age of consent as required by local legislation at the time of signature of the informed consent form (ICF).
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patient must have at least one measurable lesion outside of the central nervous system (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumour lesions that have been irradiated ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as measurable lesions only in the absence of measurable lesions that have not been irradiated.
• Further inclusion criteria apply.

Критерии исключения

• Prior treatment with systemic anticancer drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of study intervention.
• Treatment with extensive field radiotherapy including whole brain irradiation within 14 days prior to first administration.
• Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV).
• History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of III or IV, corrected QT (QTc) prolongation > 480 msec, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the Investigator.

Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to treatment.

• Further exclusion criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 5 центров

• Hospital del Mar — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitario 12 de Octubre — Madrid
• Clínica Universidad de Navarra — Navarra
• Hospital Clinico Universitario de Valencia — Valencia

Германия · 2 центра

• Technische Universität Dresden — Dresden
• Klinikum der Universität München AÖR — München

Бельгия · 1 центр

• UZ Leuven — Leuven

Нидерланды · 1 центр

• Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL) — Amsterdam

Идентификаторы

NCT: NCT07744152 · 2015-0001 · U1111-1337-2013 · 2026-525785-22-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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