A study to test different doses of BI 764532 combined with ezabenlimab in patients with Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3.

JRCT ID: jRCT2031220716

Registered date:20/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Small Cell Lung Carcinoma and other neuroendocrine neoplasms expressing DLL3.
• Date of first enrollment: 27/06/2023
• Target sample size: 4
• Countries of recruitment: Belgium,Japan,Germany,Japan,France,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Confidential information

Outcome(s)

• Primary Outcome: The primary endpoint is occurence of the DLTs within the MTD evaluation period.

Secondary Outcome

a)Occurrence of DLTs during the on-treatment period
b)Objective response, defined as best overall response of complete response(CR) or partial response(PR), where best overall response is determined by the investigators assessment according to Response Evaluation Criteria In Solid Tumors(RECIST) version 1.1 in patients with measurable disease 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.
c)The following PK parameters for BI 764532 and ezabenlimab after the first and multiple infusion cycle
C max (maximum measured concentration of the analyte)
AUC t (area under the concentration-time curve of the analyte over a uniform dosing interval t)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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 764532.
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 1.1.
e)Adequate liver, bone marrow and renal organ function

Exclude criteria

a)Previous treatment with T cell engagers or cell therapies targeting DLL3.
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 764532. 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 764532.
Patients who have been treated with extensive field radiotherapy including whole brain
irradiation within 2 weeks prior to first administration of BI 764532.
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.

Related Information

• Primary Sponsor: Mori Hiroko