Description:
The trial is an open-label, multi-center safety trial of epcoritamab GEN3013
(DuoBody®-CD3xCD20). The trial consists of two parts: a dose escalation part phase 1,
first-in-human (FIH) and an expansion part phase 2a.
Title
- Brief Title: GEN3013 Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
- Official Title: A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
GCT3013-01
- NCT ID:
NCT03625037
Conditions
- Diffuse Large B-cell Lymphoma
- High-grade B-cell Lymphoma
- Primary Mediastinal Large B-cell Lymphoma
- Follicular Lymphoma
- Mantle Cell Lymphoma
- Small Lymphocytic Lymphoma
- Marginal Zone Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|
| Epcoritamab | | Epcoritamab (GEN3013, DuoBody®-CD3xCD20) |
Purpose
The trial is an open-label, multi-center safety trial of epcoritamab GEN3013
(DuoBody®-CD3xCD20). The trial consists of two parts: a dose escalation part phase 1,
first-in-human (FIH) and an expansion part phase 2a.
Detailed Description
The purpose of the escalation part of the trial is to determine the maximum tolerated dose
and the recommended phase 2 dose (RP2D) as well as to establish the safety profile of
epcoritamab GEN3013 (DuoBody®-CD3xCD20) in patients with relapsed, progressive or refractory
B-Cell Lymphoma.
In the expansion part additional patients will be treated with epcoritamab with the RP2D and
the purpose is to further explore and determine the safety and efficacy of epcoritamab.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Epcoritamab (GEN3013, DuoBody®-CD3xCD20) | Experimental | Open label, single arm trial where Epcoritamab will be administered. | |
Eligibility Criteria
Main Inclusion Criteria Escalation Part
- Documented CD20+ mature B-cell neoplasm
1. Diffuse large B-cell lymphoma - de novo or transformed
2. High-grade B-cell lymphoma
3. Primary mediastinal large B-cell lymphoma
4. Follicular lymphoma
5. Mantle cell lymphoma
6. Small lymphocytic lymphoma
7. Marginal zone lymphoma (nodal, extranodal or mucosa associated)
- Relapsed, progressive and/or refractory disease following treatment with an anti-CD20
monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy
and/or relapsed after autologous stem cell rescue.
- ECOG performance status 0,1 or 2
- Patients must have measurable disease by CT, MRI or PET-CT scan
- Acceptable renal function
- Acceptable liver function
Main Inclusion Criteria Expansion Part
- Documented CD20 positive mature B cell neoplasm or CD20+ MCL
- Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple
hit)
- Primary mediastinal large B cell lymphoma
- Follicular lymphoma grade 3B
- Histologic confirmed follicular lymphoma
- Marginal zone lymphomas
- Small lymphocytic lymphoma
- Mantle Cell Lymphoma (prior BTKi or intolerant to BTKi)
- At least 2 therapies including an anti CD20 monoclonal antibody containing
chemotherapy combination regimen
- Either failed prior autologous hematopoietic stem cell transplantation or ineligible
for autologous stem cell transplantation due to age or comorbidities
- At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement
of 2 or more clearly demarcated lesions and or nodes
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Escalation: Adverse Events (safety) to determine the Recommended Phase 2 Dose RP2D |
| Time Frame: | Adverse Events are assessed during the first cycle (28 days) in each cohort. |
| Safety Issue: | |
| Description: | -Number of Adverse Events, treatment emergent AEs as assessed by CTCAE V5.0. |
Secondary Outcome Measures
| Measure: | Escalation and Expansion: Pharmacokinetic parameters Cmax |
| Time Frame: | Until 1 year after last patient enters the trial, through study completion. |
| Safety Issue: | |
| Description: | -PK, peak plasma concentration through concentration and half life. |
| Measure: | Escalation and Expansion: Pharmacokinetic parameters AUC |
| Time Frame: | During the first 4 doses in each patient |
| Safety Issue: | |
| Description: | -Maximum concentration AUC 0-Clast, AUC 0-x and half life. |
| Measure: | Escalation and Expansion: Immunogenicity-Anti Drug Antibody. |
| Time Frame: | Until 1 year after last patient enters the trial, through study completion. |
| Safety Issue: | |
| Description: | -ADA titers measured as positive or negative host immune response and compared to PK, safety and tumor response. |
| Measure: | Expansion: Evaluate Patient Reported Outcomes EQ-5D-3L. |
| Time Frame: | Until 1 year after last patient enters the trial, through study completion. |
| Safety Issue: | |
| Description: | -EQ-5D-3L; a six item questionnaire measuring changes from baseline; item 1 addressing a summary of the 5 next being; mobility, self care, usual activity, pain/discomfort, anxiety depression. Measured on a scale from 0 to 100, 100 being best. |
| Measure: | Expansion: Evaluate Patient Reported Outcomes FACT-Lym. |
| Time Frame: | Until 1 year after last patient enters the trial, through study completion. |
| Safety Issue: | |
| Description: | -FACT-Lym is a 2 module quality of life questionnaire measuring changes from baseline. FACT-G for quality of life and Lym a lymphoma specific questionnaire both using by a 5 point scale 0-4, 4 being best. |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Genmab |
Last Updated
July 28, 2021
