Mobilize Trial
Research type
Research Study
Full title
Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants with Advanced Solid Tumors
IRAS ID
1007567
Contact name
Asil Santos
Contact email
Sponsor organisation
ModernaTX, Inc.
Eudract number
2022-000925-26
Clinicaltrials.gov Identifier
Research summary
ModernaTx, Inc. is developing the investigational drug mRNA-4359 for cancer patients with solid tumours that can be measured, have worsened and become larger and/or spread to other parts of the body. It is thought that mRNA-4359 could help the immune system have a better chance of finding and killing cancer cells and certain types of immune cells. This study is the first time that mRNA-4359 is being given to humans.
The main purpose of this study is to test the safety and how well the body deals with the effects of mRNA-4359 when it is given alone or in combination with pembrolizumab. mRNA-4359 is designed to target and kill certain immune and cancer cells. Pembrolizumab is approved to treat certain types of cancers, by making cancer cells more visible to your immune system.
There are 3 groups to which the participants may be enrolled to receive either mRNA-4359 alone or in combination with Pembrolizumab. Enrollment into one of the 3 groups will be dependent on the type of cancer and previous cancer treatment received. Approximately 194 participants will be enrolled in several countries around the world, with approximately 10 sites in the UK.
The study will be divided into treatment or dosing “cycles” that are 3 weeks long. The number of cycles will depend on how well the study drugs are tolerated. Each participant will receive the study treatment for a maximum of 9 cycles. mRNA-4359 will be given by injection into the muscle, one dose per cycle. Up to 9 doses of mRNA-4359 will be given over approximately 6 months. Pembrolizumab will be given by infusion into a vein once every 6 weeks, together with mRNA-4359, only to participants in certain groups.
The study consists of 3 types of visits: screening visit, treatment visits, and follow-up visits. The screening visit will last up to 4 hours, and visits where participants receive study drug will last up to 5 hours. Follow-up visits will last up to 2 hours.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0150
Date of REC Opinion
21 Jul 2023
REC opinion
Further Information Favourable Opinion