GCT3013-02

• Research type

  Research Study

• Full title

  A 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

• IRAS ID

  283235

• Contact name

  Kim Linton

• Contact email

  kim.linton@christie.nhs.uk

• Sponsor organisation

  Genmab

• Eudract number

  2020-000845-15

• Clinicaltrials.gov Identifier

  NCT04663347

• Clinicaltrials.gov Identifier

  IND, 135659

• Duration of Study in the UK

  1 years, 11 months, 14 days

• Research summary

  The purpose of this trial is to investigate the safety, tolerability and efficacy of epcoritamab in patients with different subtypes of B-cell lymphoma.

  Epcoritamab is an investigational drug which will be administered as a subcutaneous injection. Epcoritamab is being combined with other cancer treatments and will be investigated under each arm. There will be five arms and for each arm, there are 2 parts: Part 1 (dose escalation) and Part 2 (expansion). Within each arm, participants can only participate in either part 1 or part 2 of this trial.

  Part 1 will include participants with subtypes of B cell lymphoma and will assess the safety of the drug and the appropriate dose of epcoritamab (that is, how much drug can be given). The dose assessed as appropriate will be used in Part 2 of the trial.

  Part 2 of the trial will further investigate the side effects and safety of the dose determined in Part 1 as well as begin to assess the ability of epcoritamab to treat lymphoma.

  Part 1 and Part 2 of each arm will consist of a screening period, a treatment period, a safety follow-up period, and a survival follow-up period.
  
  This will be a multicentre trial conducted within Europe and North America. Approximately 130 participants will be enrolled (26 per arm). A minimum of 6 participants will be enrolled in the dose escalation of each arm. Twenty participants will be enrolled in the expansion for each arm.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  20/SC/0299

• Date of REC Opinion

  10 Sep 2020

• REC opinion

  Favourable Opinion