advanced, unresectable and/or metastatic solid tumours
Conditions
Interventions
Intravenous infusion of BI 1703880 and ezabenlimab
Sponsors
Furubeppu Megumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male or female patients with histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic malignant solid tumour Patient must have exhausted or refused established treatment options known to prolong survival for the malignant disease, or is not eligible for established treatment options Patient must have at least 1 lesion amenable to pre-treatment and on-treatment biopsy ECOG 0 or 1 and life expectancy of at least >= 3 months after the start of the treatment according to the Investigator's judgement Adequate organ function or bone marrow reserve as demonstrated at screening by laboratory values
Exclusion criteria
Exclusion criteria: Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter Radiation therapy within 4 weeks prior to the first treatment Prior STING agonist therapy Prior intolerability of a PD-1 or anti-PD-L1 therapy Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding >10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers Persistent toxicity from previous treatments (including irAEs) that has not resolved to Grade <=1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies History or evidence of active, non-treatment related autoimmune disease, except for endocrinopathies History of pneumonitis related to prior immunotherapy Positive and confirmed SARS-COV-2 test on Cycle 1 Day 1. Presence of other active invasive cancers other than the one treated in this trial within 3 years prior to screening Presence or history of uncontrolled or symptomatic brain or subdural metastases unless local therapy has ended, and metastases considered stable for at least the prior three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of DLTs during the MTD evaluation period | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of DLTs during the on-treatment period PK parameters Cmax and AUC0-tz | — |
Countries
Japan, Spain, United Kingdom, United States
Contacts
Public ContactTetsuya Katakabe
Nippon Boehringer Ingelheim Co., Ltd.
Outcome results
None listed