ARTEMIDE-01

• Research type

  Research Study

• Full title

  A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non small Cell Lung Cancer (ARTEMIDE-01)

• IRAS ID

  1005535

• Contact name

  Abhijit Nair

• Contact email

  abhijit.nair@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2021-000857-23

• Research summary

  The overall aim of the study is to gather information on the correct dosing of AZD2936 and to understand if this new medicine can be useful for the management of unresectable or metastatic NSCLC. AZD2936 is a new antibody that blocks two proteins, namely PD-1 and TIGIT.
  Both proteins are so called “immune checkpoints”. These proteins provide signals that hinder the body’s immune system from attacking tumour cells. The bispecific format of AZD2936 aims to block both these signals at the same time, thereby increasing the immune system’s ability to attack the tumour.

  There are three parts to this study:
  Part A – Dose escalation: Each participant will be assigned to a prespecified dose of AZD2936 to determine the optimal dose for safe treatment. Once enough participants have been treated with a specific dose of AZD2936, the dose for subsequent participants may be increased if it is considered safe to do so. Up to 72 participants will be participating in Part A.
  Part B – Dose expansion: Up to 30 additional participants will be treated with AZD2936 at the optimal dose determined in Part A. With this cohort, the study aims to better understand the side effects and also possibly the antitumor therapeutic effects of AZD2936.
  Part C - Dose expansion: Up to 30 participants whose tumour has not been treated with another medication blocking immune checkpoints will be treated with AZD2936 at the optimal dose. The aim of this cohort is to better understand the side effects and antitumor therapeutic effects of AZD2936. In the UK, participants will only enter part C.
  In total, up to 132 participants with advanced or metastatic NSCLC will be treated in this study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  22/LO/0625

• Date of REC Opinion

  8 Nov 2022

• REC opinion

  Further Information Unfavourable Opinion