Phase I, non-randomised, open-label, multi-centre dose escalation and expansion trial of BI 765049 and BI 765049 + ezabenlimab administered by repeated intravenous infusion in Asian patients with malignant solid tumours expressing B7-H6

Hagimori Kenta0 个研究点目标入组 70 人开始时间: 2024年1月26日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•. >=18 years of age.
•. Histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic GC, CRC, PDAC, HCC, HNSCC, or NSCLC.
•. Agree to the collection of tumour samples (as slides from archival diagnostic samples or fresh tumour biopsies) for confirmation of B7-H6 expression
•. Confirmed B7-H6 expression on tumour tissue sample (archived or fresh tumour biopsy) based on central pathology review except for patients diagnosed with advanced or metastatic CRC
•. Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options.
•. Evaluable target lesion for response assessment outside of the central nervous system as defined per RECIST v1.1.
•. Adequate organ function as specified in Section 3.3.2

•. Any investigational or antitumour treatment within 21 days or 5 half-life periods prior to the first treatment, whichever is shorter.
•. Previous treatment with a B7-H6 targeting agent
•. For Parts III and IV, prior intolerable toxicity (as judged by the Investigator) to PD-1 or anti-PD-L1 therapy.
•. Diagnosis of immunodeficiency within 7 days prior to the first dose of BI 765049
•. History of immunosuppressive medication within 14 days prior to the first dose of BI 765049, with some exceptions
•. Persistent toxicity from previous treatments (including irAEs) that has not resolved to Grade 1, except for alopecia, Grade 2 neuropathy, or endocrinopathies controlled by replacement therapy
•. Evidence of active, non-treatment related autoimmune disease, with some exceptions.
•. History of/active non-infectious pneumonitis or interstitial lung disease of any grade
•. Infection requiring systemic antimicrobial, antiviral, antiparasitic or antifungal therapy at the start of treatment in the trial.

发起方

Hagimori Kenta