2023-505347-38-00招募中2 期
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 38
- 主要终点
- The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.
研究概览
简要总结
The primary objectives of the study are to characterize the safety, toxicity and tolerability profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult male or female, at least 18 years old
- •(Arms 1, 2, 3, and 4) Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to WHO 2016 classification and documented in pathology report: DLBCL, not otherwise specified (NOS) - High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per World Health Organization (WHO) 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible - FL Grade 3B OR FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR MCL with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or PCR
- •Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2, except for Arms 6, 7 and 8where ECOG performance status must be 0-1
- •Subject must have 1 or more measurable disease sites: A positron emission tomography/computed tomography (PET/CT) scan demonstrating PET-positive lesion(s) AND - At least 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI
排除标准
- •Diagnosis of High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL)
- •Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20
结局指标
主要结局
The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.
The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.
次要结局
- Best overall response (BOR) by Lugano 2014 criteria as assessed by investigator for epcoritamab in combination with other antineoplastic agents.
- Antilymphoma activity of epcoritamab in combination with other antineoplastic agents: - Duration of response determined per Lugano 2014 criteria as assessed by investigator. - Progression free survival determined per Lugano 2014 criteria as assessed by investigator. - Complete response during the study determined per Lugano 2014 criteria as assessed by investigator. - Time to response determined per Lugano 2014 criteria as assessed by investigator. - Time to next antilymphoma therapy.
研究者
Global Clinial Trial Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (38)
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