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

• Status: Not yet recruiting
• Trial end date: 2023-12-11
• Target enrollment: 0
• Participant gender: All

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 20 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 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP or 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborator: Genmab
• Treatments: Cyclophosphamide; Doxorubicin; Lenalidomide; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

All Cohorts:

• 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 measurable extra-nodal lesion (long axis >= 1 cm) on CT scan or MRI.

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 (HGBL) with MYC and BCL2 and/or BCL6 rearrangements 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 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.

Cohort 1 Part 2 (Monotherapy Expansion) Specific Criteria:

• Must have histologically confirmed CD20+ DLBCL (de novo or transformed) at most recent (previous or current) representative tumor biopsy based on the pathology report, according to the World Health Organization (WHO) 2016 classification

• Following safety run-in and up to the 12th participant (including the number of safety run-in participants) in Cohort 1, participant must have received at least 1 prior line of systemic therapies which must include an anti-CD20 monoclonal antibody containing combination therapy (e.g., rituximab). After 12 participants have been enrolled at dose A of epcoritamab, participants must have received at least 2 prior lines of systemic therapies.

• Either failed prior autologous HSCT, or ineligible for autologous HSCT due to age or comorbidities.

Cohort 2 Specific Criteria:

• Must have newly diagnosed DLBCL.

• Double-/triple-hit DLBCL (categorized in WHO 2016 as high-grade B-cell lymphoma [HGBCL] with MYC and BCL2 and/or BCL6 rearrangements)*

• Note: other histologies with MYC and BCL2 and/or BCL6 translocations are excluded.

• Eligible for standard R-CHOP for 6 cycles.

Cohort 3 Specific Criteria:

• Must have histologically confirmed Grade 1 - 3a Follicular Lymphoma with no evidence of histologic transformation to an aggressive lymphoma at most recent (previous or current) representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report, according to the WHO 2016 classification.

• Must have R/R disease to at least one prior treatment which must include an anti-CD20 monoclonal antibody (e.g., rituximab).

• Must be eligible for R2 per investigator determination.

Exclusion Criteria:

All Cohorts:

• History of primary mediastinal lymphoma.

Cohort 2 Specific Criteria:

• History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids.