A Phase 1/2a Study to Assess AFM24 with Atezolizumab in selected Advanced/Metastatic EGFR+ Cancers

• Research type

  Research Study

• Full title

  A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic EGFR-expressing Cancers

• IRAS ID

  1003783

• Contact name

  Erika Johnson-Froneberg

• Contact email

  e.johnson-froneberg@affimed.com

• Sponsor organisation

  Affimed GmbH

• Eudract number

  2021-000707-20

• Research summary

  This phase 1/2a study aims to find a safe dose of AFM24 in combination with atezolizumab in patients with Epidermal Growth Factor Receptor positive (EGFR+) advanced solid cancers and then test the tolerability and anticancer effect of this AFM24 dose in combination with atezolizumab in specific EGFR+ cancer-patient populations.
  AFM24 is a newly developed antibody drug designed to link tumour cells with the EGFR on their surface to cells of the immune system known as ‘natural killer’ cells, and thereby cause tumour cell death. Atezolizumab is an approved antibody drug, which works against cancer by attaching to a protein called PD-1 on the surface of cancer cells and consequently helping the body’s immune system to attack cancer cells more aggressively.
  This study will comprise a dose escalation phase (with approximately 18 patients) followed by a dose expansion phase (with 147 patients). The aim of the dose escalation phase is to determine the Maximum Tolerated Dose of AFM24 given in combination with an approved dose of atezolizumab and establish the AFM24 dose to be given with atezolizumab in the dose expansion phase. The dose expansion part of the study is intended to collect initial evidence of anti-tumour activity and to further confirm the safety of AFM24 combined with atezolizumab in adult patients with solid cancers whose disease has progressed after treatment with previous anticancer therapies.
  This is an open (the investigator and the patient will know what drugs are given), uncontrolled (all participants will receive the study drugs), study and is planned to run in 1 hospital in the UK, 1 hospital in Europe and a further 3 hospitals in the US.
  The study consists of a prescreening tumour EGFR test, a screening period of up to 21 days; a 7-day AFM24 safety lead-in phase; a treatment period lasting until disease progression, an intolerable adverse event or withdrawal of the patient occurs and a post-treatment period lasting until the end of the study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  21/LO/0687

• Date of REC Opinion

  18 Nov 2021

• REC opinion

  Further Information Favourable Opinion