GCT3013-03: safety and efficacy study of epcoritamab in patients with R/R CLL and RS
Research type
Research Study
Full title
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome
IRAS ID
1006575
Contact name
Jacob Hansen
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2020-000848-57
Clinicaltrials.gov Identifier
Research summary
The purpose of this Phase 1b/2 study is to evaluate the safety and preliminary efficacy of single agent Epcoritamab in participants with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) and Richter’s syndrome (RS). This study is sponsored by Genmab A/S. Around 102 research participants globally, will take part in this study. The trial will be conducted in 2 parts. Part 1 (Dose Escalation) and Part 2 (Expansion). All participants will receive the study drug Epcoritamab and is administered as a Subcutaneous (SC) (under the skin) injections.
Part 1 is complete. The primary objective in Part 1 was to identify the recommended Part 2 dose and assess the safety of the drug and the appropriate dose of Epcoritamab (that is, how much drug can be given to participants). Epcoritamab was tested at 2 full dose levels 24 mg and 48 mg. The dose assessed as appropriate is to be used in Part 2 of the study, which will further investigate the tolerability and safety of the determined dose level. In part 2, eligible patients will receive the study drug Epcoritamab by SC injection. The primary objective in Part 2 is to assess the preliminary efficacy, safety and tolerability of epcoritamab at the recommended Part 2 dose.
Both Part 1 and Part 2 of the study are divided into 3 phases which participants will undergo, if they are eligible and decide to participate. These phases are called: Screening, Treatment- and Follow-up phase. Each treatment cycle is 28 days. Epcoritamab is administered in 4-week cycles (ie, 28 days) weekly in Cycles 1, 2, and 3; biweekly in Cycles 4 to 9, then monthly from Cycle 10 onwards. Maximum trial duration is 5 years.
Part 1 was conducted in Germany, Belgium, the Netherlands, and USA in those with CLL and Epcoritamab 48 mg dose level was identified as the recommended Part 2 dose.REC name
HSC REC A
REC reference
22/NI/0174
Date of REC Opinion
27 Jun 2023
REC opinion
Further Information Favourable Opinion