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ACTIVE NOT RECRUITING
NCT05201248
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Epcoritamab

Subcutaneous Injection (SC)

DRUG

Cyclophosphamide

IV Injection

DRUG

Rituximab

Intravenous (IV) Infusion

DRUG

Doxorubicin

IV Infusion

DRUG

Vincristine

IV Infusion

DRUG

Prednisone

Oral; Tablet

DRUG

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