An open label trial of BI 765063 in combination with BI 754091 (ezabenlimab) alone or with BI 836880, chemotherapy, or cetuximab, in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or hepatocellular carcinoma (HCC)

Tsunoda Toru0 个研究点目标入组 150 人开始时间: 2022年3月8日最近更新: 2024年5月27日

研究概览

暂无简介。

•Patients homozygous for V1 allele (including V1-like alleles) of SIRPa
•Patients with at least one measurable lesion as per RECIST v1.1
•Eastern Cooperative Oncology Group (ECOG) performance status <=1
•For patients with HNSCC only (Cohorts A and B)
•Patients with recurrent or metastatic histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx which is considered incurable by local therapies (e.g. surgery, radiotherapy).
•Immune checkpoint inhibitor naive patients who progressed on a standard platinum-based therapy in the recurrent/metastatic setting.
•For patients with HCC only (Cohorts C, D, and E)
•Patients with locally advanced/metastatic and/or unresectable HCC as confirmed histologically or by diagnostic imaging (dynamic Computed Tomography CT or Magnetic Resonance Imaging MRI) according to AASLD criteria
•60 patients who have not received prior systemic therapy will be randomized in 2 1st line HCC.
•30 patients who have progressed on 1st line atezolizumab+bevacizumab therapy/regimen will be included in a 2nd line HCC.
•Child-Pugh Score of A.

•Patients with at least one SIRPa V2 allele, i.e. SIRPa V1/V2 or V2/V2 individuals.
•Previous treatment with any anti-PD-(L)1, anti-SIRPa, or anti-VEGF (for cohorts using BI 836880 only), except for patients treated in 2nd line HCC cohort where previous treatment with atezolizumab+bevacizumab is required.
•For patients with HNSCC only (Cohorts A and B )
•Patients with nasopharyngeal carcinoma.
•For patients with HCC only (Cohorts C, D and E)
•Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
•Tumour of diffuse infiltrative HCC type (hypovascular infiltrative tumours with ill-defined borders).
•Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
•History of recent bleeding disorders or risk of bleeding (including history of fistulae, GI perforation, or intra-abdominal abscess) within 6 months of initiation of study treatment.
•Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding

发起方

Tsunoda Toru