Status and phase
Conditions
Treatments
About
This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful and for whom no other treatment options exist can join the study.
The purpose of this study is to find the highest dose of BI 770371 that people with advanced cancer can tolerate when taken alone or together with a medicine called ezabenlimab.
BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer (checkpoint inhibitors). In this study, BI 770371 is given to people for the first time.
Participants get BI 770371 alone or together with ezabenlimab as an infusion every 3 weeks.
It is planned that participants can stay in the study for up to 2 years, if they benefit from treatment and can tolerate it. During this time, they visit the study site regularly.
The doctors collect information on any health problems of the participants. The doctors also regularly monitor the size of the tumour.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Major surgery (major according to the Investigator's assessment) performed within 12 weeks prior to randomisation or planned within 12 months after screening, e.g. hip replacement
Presence of active invasive cancers other than the one treated in this trial within 5 years prior to screening, with the exception of appropriately treated basal-cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local tumours considered cured by local treatment
Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of Progressive Disease (PD) by imaging for at least 4 weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases
Radiotherapy within 4 weeks prior to randomisation except as follows:
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
History of pneumonitis within the last 5 years or Interstitial lung disease
Known history of allergy to any trial drug, or any excipients of the trial drug(s)
History of severe hypersensitivity reactions and/or severe infusion related reactions (Grade ≥ 3 National Cancer Institute (NCI) CTCAE v5.0) to other Monoclonal Antibodies (mAbs) Further exclusion criteria apply
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
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Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
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