The Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma

Recruiting

• Conditions: B-cell Non-Hodgkin Lymphoma; B-cell Non-Hodgkin Lymphoma cancer; 10025320

• Registration Number: NL-OMON54276
• Lead Sponsor: Genmab

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Subject must sign an ICF
2. At least 18 years of age
3. Measurable disease defined as >=1 measurable nodal lesion (long axis >1.5 cm
and short axis >1.0 cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm)
on CT or MRI
4. ECOG PS score of 0, 1 or 2
5. Acceptable organ function at screening
6. CD20-positive NHL at representative (previous or current) tumor biopsy
7. If of childbearing potential subject must practicing a highly effective
method of birth control
8. A man who is sexually active with a woman of childbearing potential must
agree to use a barrier method of birth control
9. Life expectancy > 2 months with SoC treatment

Arm 1: One of these confirmed histologies:
- DLBCL, NOS
- T-cell / histiocyte rich DLBCL
- double-hit or triple-hit DLBCL
- FL Grade 3B

Arm 2 and Arm 9: R/R FL

Arm 3: Newly diagnosed, previously untreated FL grade 1-3A

Arm 4 and arm 10: One of these confirmed histologies and eligible for HDT-ASCT:
- DLBCL, NOS
- T-cell / histiocyte rich DLBCL
- double-hit or triple-hit DLBCL
- FL Grade 3B

Arm 5: One of these confirmed histologies and ineligible for HDT-ASCT:
- DLBCL, NOS
- T-cell / histiocyte rich DLBCL
- double-hit or triple-hit DLBCL
- FL Grade 3B

Arm 6: previously untreated CD20+ FL

Arm 7: FL and in CR or PR per Lugano criteria following first-line or
second-line treatment with SOC regiment and last dose of SOC within 6 months
prior to enrollment

Arm 8: One of these confirmed histologies:
- DLBCL, NOS
- T-cell/histiocyte rich DLBCL
- double-hit or triple-hit DLBCL
- FL Grade 3B
For Arm 8, subjects must be ineligible to receive full-dose anthracycline (as
part of R-CHOP) per eligibility criteria

Arm 9: Must have received only 1 prior line of therapy. This first-line therapy
must have included an anti-CD20 antibody in combination with chemotherapy.
Progressed within 24 months of initiating first-line treatment

Exclusion Criteria

1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to
the first dose of epcoritamab
2. Any prior treatment with a bispecific antibody targeting CD3 and CD20
3. Treatment with CAR-T therapy within 100 days prior to first dose of
epcoritamab
4. Clinically significant cardiac disease
5. Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol or interpretation of results
6. CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed
by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
7. Active HBV or HBC (DNA PCR positive infection)
8. Known history of seropositivity of human immunodeficiency virus (HIV)
9. Active tuberculosis or history of completed treatment for active
tuberculosis within the past 12 months
10. Subject has current seizure disorder requiring anti-epileptic therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dose Escalation Phase<br /><br>- Incidence of dose-limiting toxicities<br /><br>- Incidence and severity of adverse events (AEs)<br /><br>- Incidence and severity of changes in laboratory values<br /><br>- Incidence of dose interruptions and delays<br /><br><br /><br>Expansion Phase:<br /><br>Arms 1-6 and 8-10:<br /><br>- ORR determined by Lugano criteria<br /><br>Arm 7:<br /><br>- Incidence and severity of AEs<br /><br>- Incidence and severity of changes in laboratory values<br /><br>- Incidence of dose interruptions and delays</p><br>