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
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
1 other identifier
interventional
49
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2022
Typical duration for phase_1
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2022
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJanuary 7, 2025
January 1, 2025
3.1 years
January 18, 2022
January 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR)
Best overall response (BOR) is defined as the percentage of participants in Cohort 1 Part 2 third line plus (3L) R/R DLBCL who achieved best overall response of complete response (CR) or partial response (PR) by Lugano 2014 criteria as assessed by independent review committee (IRC).
Up to Approximately 5 Years
Cohort 1 Part 1, Cohort 2, and Cohort 3: Number of Incidence of Dose-Limiting Toxicities (DLT)
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Up to Approximately 5 Years
Secondary Outcomes (5)
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Percentage of Participants with Complete Remission (CR)
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Number of Participants with Progression-free survival (PFS)
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Overall survival (OS)
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Duration of response (DOR)
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Time-to-response (TTR)
Up to Approximately 5 Years
Study Arms (4)
Cohort 1 Part 1: Epcoritamab Monotherapy
EXPERIMENTALParticipants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Cohort 1 Part 2: Epcoritamab Expansion
EXPERIMENTALParticipants will receive SC epcoritamab in 28 day cycles.
Cohort 2: Epcoritamab + RCHOP
EXPERIMENTALParticipants will receive SC epcoritamab in combination with \[intravenously (IV) infused rituximab, IV injected cyclophosphamide, IV infused doxorubicin, IV infused vincristine, and oral prednisone (R-CHOP)\] in 21 day cycles followed by 28 day cycles.
Cohort 3: Epcoritamab + R2
EXPERIMENTALParticipants will receive SC epcoritamab in combination with \[intravenously (IV) infused rituximab, and oral lenalidomide (R2)\] in 28 day cycles.
Interventions
Subcutaneous Injection (SC)
Eligibility Criteria
You may qualify if:
- All Cohorts:
- Life expectancy of \>= 3 months on standard of care (SOC).
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2.
- Has one or more measurable disease sites:
- Fluorodeoxyglucose-positron emission tomography (FDGPET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites.
- \>= 1 measurable nodal lesion (long axis \> 1.5 cm and short axis \> 1.0 cm) or \>= 1.0 measurable extra-nodal lesion (long axis \>= 1 cm) on CT scan or MRI. Note: A previously irradiated lesion must have demonstrated progression or residual disease in the lesion after radiotherapy to be considered measurable.
- Cohort 1 Part 1 (Monotherapy Safety Run-in) Specific Criteria:
- Must have histologically confirmed CD20+ Diffuse large B-cell lymphoma (DLBCL), or High-grade B-cell lymphoma (HGCBL) with MYC and BCL2 and/or BCL6 translocations and DLBCL feature, and follicular Lymphoma (FL) at most recent (previous or current) representative tumor biopsy based on the pathology report, according to the World Health Organization (WHO) 2016 (or later) classification.
- Must have at least one prior treatment with an anti-CD20 monoclonal antibody (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
- Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred \>= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (\<6 months) of completion of therapy.
- Cohort 1 Part 2 (Monotherapy Expansion) Specific Criteria:
- Must have histologically confirmed CD20+ DLBCL at most recent (previous or current) representative tumor biopsy based on the pathology report, inclusive of the following according to the World Health Organization (WHO) 2016 (or later) classification.
- DLBCL, not otherwise specified (NOS) including de novo or histologically transformed from an earlier diagnosis of indolent lymphoma such as FL and nodal marginal zone lymphoma with a subsequent development of DLBCL relapse or.
- "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Double- /triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible.
- FL Grade 3B.
- +15 more criteria
You may not qualify if:
- All Cohorts:
- History of primary mediastinal lymphoma.
- Autologous Stem Cell Transplantation within 100 days prior to enrollment.
- Have received prior allogeneic hematopoietic stem cell transplantation at any time.
- Have been treated with a bispecific antibody targeting CD3 and CD20.
- Cohort 2 Specific Criteria:
- \- History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
The Fifth Medical Center of PLA General Hospital /ID# 230520
Beijing, Beijing Municipality, 100071, China
Peking University Third Hospital /ID# 228138
Beijing, Beijing Municipality, 100191, China
Fujian Medical University Union Hospital /ID# 231890
Fuzhou, Fujian, 350001, China
Sun Yat-Sen University Cancer Center /ID# 228033
Guangzhou, Guangdong, 510060, China
Guangdong Provincial People's Hospital /ID# 228028
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University /ID# 227916
Guangzhou, Guangdong, 510515, China
Henan Cancer Hospital /ID# 228772
Zhengzhou, Henan, 450008, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital /ID# 231859
Changsha, Hunan, 410006, China
The First Affiliated Hospital of Soochow University /ID# 228024
Suzhou, Jiangsu, 215006, China
The Affiliated Hospital of Xuzhou Medical College /ID# 228774
Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital of Nanchang University /ID# 228771
Nanchang, Jiangxi, 330006, China
Jiangxi Provincial Cancer Hospital /ID# 231944
Nanchang, Jiangxi, 330029, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724
Shanghai, Shanghai Municipality, 200065, China
West China Hospital, Sichuan University /ID# 231434
Chengdu, Sichuan, 610041, China
Tianjin Cancer Hospital /ID# 228135
Tianjin, Tianjin Municipality, 300000, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer hospital /ID# 228776
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2022
First Posted
January 21, 2022
Study Start
March 10, 2022
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
January 7, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.