mRNA-4157 alone and in combination in participants with solid tumours

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants with Solid Tumors

• IRAS ID

  1008680

• Contact name

  Kabir Mody

• Contact email

  kabir.mody@modernatx.com

• Sponsor organisation

  ModernaTX, Inc.

• Clinicaltrials.gov Identifier

  NCT03313778

• Research summary

  A vaccine is a substance used to teach the immune system to fight against a certain disease. An important feature of the immune system is that it is much stronger when fighting a disease which it has come across before. For this study, the sponsor will make a personalised cancer vaccine called mRNA-4157 that is designed against the specific cancer that was removed during surgery.

  The purpose of the study is to test the safety and how well the body deals with effects of mRNA-4157, and to find the best dose for future studies. This study will also look at whether mRNA-4157 affects the immune system. Different parts of this study will look at the effects of mRNA-4157 when given in combination with pembrolizumab and with standard of care (SOC) chemotherapy.

  The UK will participate in:
  - Part A2 – participants with pancreatic cancer will receive mRNA-4157 and SOC chemotherapy for a portion of this time
  - Parts E – participants with lung or gastric cancer will receive mRNA-4157 with pembrolizumab and SOC chemotherapy

  mRNA-4157 will be given by intramuscular injection every 3 weeks (for up to 9-16 doses).

  Participants may remain in the study for 12-18 months with study visits every 1-3 weeks. Study procedures will include physical examinations, vital signs, ECG, blood and urine samples, imaging scans, review of archival tumour samples and apheresis (select sites only). A safety check up will be performed one week and 100 days after the last dose of mRNA-4157. Follow-up will continue every 12 weeks to assess disease status.

  The study is sponsored by ModernaTX, Inc. Approximately 174 patients will participate in this study in the UK, Australia, USA and Japan, with 18 patients from 5 hospitals in the UK.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0127

• Date of REC Opinion

  30 Apr 2024

• REC opinion

  Further Information Favourable Opinion