Phase Ia, first in human open label dose escalation trial evaluating intravenous BI 1703880 in combination with intravenous ezabenlimab for treatment of advanced solid tumours

Nippon Boehringer Ingelheim Co., Ltd.0 个研究点目标入组 66 人开始时间: 2023年1月19日最近更新: 2024年8月20日

试验速览

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•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

•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
•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

Occurrence of DLTs during the MTD evaluation period

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