A Phase I, non-randomized, open-label, multi-center dose escalation trial of BI 764532 combined with ezabenlimab in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3.

Boehringer Ingelheim0 个研究点目标入组 4 人开始时间: 待定最近更新: 2023年7月15日

试验速览

暂无简介。

•a)Signed and dated, written informed consent form (main ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.
•b)Locally advanced, metastatic or relapsed cancer not amenable to curative treatment; of following histologies:
•Small cell lung carcinoma (SCLC)
•Large cells neuroendocrine lung carcinoma (LCNEC)
•Neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin
•Tumours must be positive for DLL3 expression (on archived tissue) according to
•central pathology review in order to start BI
•c)Patient has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy. Previous therapy with anti PD-1 or PD-L1 are allowed
•d)At least one evaluable lesion outside of CNS as defined per RECIST 1.
•e)Adequate liver, bone marrow and renal organ function

•a)Previous treatment with T cell engagers or cell therapies targeting DLL
•b)Persistent toxicity from previous treatments that has not resolved to =< CTCAE Grade1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy).
•c)Patient has a diagnosis of immunodeficiency or is receiving immunosuppressive steroid doses (>10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI
•Physiological replacement of steroids is allowed.
•d)Patient with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment (i.e. corticosteroids or immunosuppressive drugs).
•e)Prior anti-cancer therapy:
•Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5
•half-life periods (whichever is shorter) prior to first administration of BI
•Patients who have been treated with extensive field radiotherapy including whole brain
•irradiation within 2 weeks prior to first administration of BI
•f)Women who are pregnant, nursing/breast feeding or who plan to become pregnant or nurse
•while in the trial or within 3 months after the last dose of study treatment.

The primary endpoint is occurence of the DLTs within the MTD evaluation period.

Occurrence of DLTs during the on-treatment period(on-treatment period)
Objective response(from date of first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti cancer therapy, loss to follow up or withdrawal of consent)
PK parameters for BI 764532 and ezabenlimab

发起方