D7986C00001 GEMINI Gastric

• Research type

  Research Study

• Full title

  A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

• IRAS ID

  1006955

• Contact name

  Soumya Boucelham

• Contact email

  soumya.boucelham@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2022-002840-29

• Research summary

  The overall aim of the study is to gather information on the safety, tolerability, efficacy, and how the body processes two drug molecules (AZD2936 and MEDI5752) in combination with either chemotherapy (FOLFOX or XELOX) and also to better understand gastric cancer and associated health problems.

  AZD2936 and MEDI5752 are both new drug molecules that bind to two different proteins at the same time, and are therefore called “bispecific antibodies”: AZD2936 binds to the PD-1 and TIGIT proteins whereas MEDI5752 binds to the PD-1 and CTLA-4 proteins.
  These proteins also known as “immune checkpoints” which provide signals that prevent the body’s immune system from attacking tumour cells.
  The bispecific format of AZD2936 and MEDI5752 aims to block both these signals at the same time, thereby increasing the immune system’s ability to attack the tumour.

  There are 2 sub-studies as part of this protocol:
  Sub-study 1 - MEDI5752 plus XELOX or FOLFOX
  Sub-study 2 - AZD2936 plus XELOX or FOLFOX

  HER 2 negative gastric cancer patients whose cancer cannot be operated on or whose cancer has spread will be assessed for their eligibility according to the protocol by their Study Doctor, and eligible patients will be assigned to one sub-study to receive treatment of one of the bispecific plus chemotherapy. The choice of chemotherapy will be based on Investigators’ discretion.

  The study is designed as a platform study, and new sub-studies may be added based on emerging data at a later date. The maximum treatment period is 24 months, final database lock (DBL) is expected in year 2025 for the current two sub-studies, the date may be prolonged if new sub-studies added.
  Astrazeneca is the sponsor of this study, and patients will be recruited from UK, Spain, USA, Taiwan, South Korea, Japan and China from sites experienced with early clinical studies.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  23/LO/0029

• Date of REC Opinion

  24 Aug 2023

• REC opinion

  Further Information Favourable Opinion