A Study of ALX148 in Patients with Advanced Gastric Cancer

• Research type

  Research Study

• Full title

  A Phase 2/3 Study of ALX148 in Patients with Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

• IRAS ID

  300932

• Contact name

  Ian Chau

• Contact email

  ian.chau@rmh.nhs.uk

• Sponsor organisation

  ALX Oncology Inc.

• Eudract number

  2021-001008-14

• Clinicaltrials.gov Identifier

  NCT05002127

• Clinicaltrials.gov Identifier

  IND Number, 153306

• Duration of Study in the UK

  5 years, 0 months, 0 days

• Research summary

  The purpose of this research study is to study the effectiveness of the study medication, ALX148, in combination with trastuzumab, ramucirumab, and paclitaxel for treating gastric or gastroesophageal cancer.
  The study will also assess safety and tolerability of ALX148 with trastuzumab, ramucirumab, and paclitaxel, to document the levels of ALX148 in the blood, and to document the effects of ALX148 on cancer together with trastuzumab, ramucirumab, and paclitaxel.
  Participants will either be given ALX148 in combination with trastuzumab, ramucirumab, and paclitaxel or will receive trastuzumab, ramucirumab, and paclitaxel alone. Participants will be randomly assigned to one of the treatments and will have a 50% chance of receiving ALX148 in combination with trastuzumab, ramucirumab, and paclitaxel (compared to receiving trastuzumab, ramucirumab, and paclitaxel alone).
  ALX148 is a new investigational medication. ALX148 is a fusion protein (a protein generated by joining parts of two different proteins), which has been shown in animal studies to help the immune system destroy cancer cells. The other medications used in this study, trastuzumab, ramucirumab, and paclitaxel, are approved for treatment of gastric or gastroesophageal cancer.
  The study will be performed in the UK as two phases, phase 2 and 3.

  In phase 2, approximately 100 patients will be recruited. Each patient will receive one of the below treatment arms:
  - ALX148 with trastuzumab, ramucirumab, paclitaxel OR
  - Trastuzumab, ramucirumab, and paclitaxel

  In phase 3, approximately 350 patients will be recruited. Each patient will receive:
  - ALX148 with trastuzumab, ramucirumab and paclitaxel OR
  - Placebo medication with ramucirumab and paclitaxel

  Participants will be in the research study as long as they benefit from study treatment.

• REC name

  West of Scotland REC 1

• REC reference

  21/WS/0109

• Date of REC Opinion

  21 Oct 2021

• REC opinion

  Further Information Favourable Opinion