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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
137
BI 3822971
UZ Leuven
Leuven, Belgium
NOT_YET_RECRUITINGShanghai East Hospital
Shanghai, China
NOT_YET_RECRUITINGTechnische Universität Dresden
Dresden, Germany
NOT_YET_RECRUITINGKlinikum der Universität München AÖR
München, Germany
NOT_YET_RECRUITINGNederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, Netherlands
NOT_YET_RECRUITINGHospital del Mar
Barcelona, Spain
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Spain
NOT_YET_RECRUITINGHospital Universitario 12 de Octubre
Madrid, Spain
RECRUITINGClínica Universidad de Navarra
Navarra, Spain
RECRUITINGHospital Clinico Universitario de Valencia
Valencia, Spain
NOT_YET_RECRUITINGOccurrence of treatment-emergent adverse events (AEs)
Time frame: up to 36 months
Occurrence of dose limiting toxicities (DLTs)
Time frame: up to 36 months
Maximum measured concentration (Cmax) of BI 3822971 in plasma
Time frame: up to 36 months
Area under the concentration-time curve (AUC) of BI 3822971 in plasma
Time frame: up to 36 months
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