[M22-132] 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

JRCT ID: jRCT2011220044

Registered date:14/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: B-cell non-Hodgkin lymphoma
• Date of first enrollment: 28/08/2023
• Target sample size: 132
• Countries of recruitment: United States,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Korea,Japan,Netherlands,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

- Arm 2: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
- Arm 3: Dose Expansion
Participants newly diagnosed treatment-naive DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.

Outcome(s)

• Primary Outcome: Dose Limiting Toxicities (DLTs)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Diagnosis of diffuse large B-cell lymphoma (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 World Health Organization (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 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.
--Follicular lymphoma Grade 3B.
-Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
-Must have 1 or more measurable disease sites:
--A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
--At least 1 measurable nodal lesion (long axis >= 1.5cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.

Exclude criteria

-Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
-Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia.

Related Information

• Primary Sponsor: Satomi Natsuko
• Secondary Sponsor: Genmab K.K.
• Secondary ID(s): NCT05283720