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A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma
Sponsor: Genmab
Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy \[Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenalidomide (R2)\] in adult participants in China with B-Cell Non-Hodgkin Lymphoma. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of B-Cell Non-Hodgkin Lymphoma. Study doctors put the participants in groups called treatment arms. A monotherapy of epcoritamab and two different combination of epcoritamab with standard of care therapy (R-CHOP or R2) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. Approximately 66 adult participants with B-Cell Non-Hodgkin Lymphoma will be enrolled in the study in approximately 21 sites in China. In the monotherapy arm (Cohort 1), participants will receive subcutaneous epcoritamab in 28-day cycles. In the combination arms (Cohorts 2 and 3), participants in Cohort 2 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP) in 21-day cycles followed by 28-day cycles, participants in Cohort 3 will receive subcutaneous epcoritamab with standard of care therapy (R2) in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Official title: Phase 1b/2, Open-Label Trial to Evaluate Safety and Preliminary Efficacy of Epcoritamab As Monotherapy or Combined With Standard-of-Care Therapies in Chinese Subjects With B-Cell Non-Hodgkin Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
49
Start Date
2022-03-10
Completion Date
2025-04
Last Updated
2025-01-07
Healthy Volunteers
No
Conditions
Interventions
Epcoritamab
Subcutaneous Injection (SC)
Cyclophosphamide
IV Injection
Rituximab
Intravenous (IV) Infusion
Doxorubicin
IV Infusion
Vincristine
IV Infusion
Prednisone
Oral; Tablet
Lenalidomide
Oral; Capsule
Locations (18)
The Fifth Medical Center of PLA General Hospital /ID# 230520
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 228138
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital /ID# 231890
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center /ID# 228033
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital /ID# 228028
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 227916
Guangzhou, Guangdong, China
Henan Cancer Hospital /ID# 228772
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221
Wuhan, Hubei, China
Hunan Cancer Hospital /ID# 231859
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University /ID# 228024
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College /ID# 228774
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 228771
Nanchang, Jiangxi, China
Jiangxi Provincial Cancer Hospital /ID# 231944
Nanchang, Jiangxi, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University /ID# 231434
Chengdu, Sichuan, China
Tianjin Cancer Hospital /ID# 228135
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154
Hangzhou, Zhejiang, China
Zhejiang Cancer hospital /ID# 228776
Hangzhou, Zhejiang, China