Safety and efficacy of SOT101 & pembrolizumab in patients with advanced/refractory solid tumors
Research type
Research Study
Full title
A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors
IRAS ID
1005257
Contact name
Elliott Olsen
Contact email
Sponsor organisation
SOTIO Biotech AG
Eudract number
2021-005774-25
Research summary
Immunotherapies have a major role in treating cancers as the immune system can control tumour growth. Two cancer immunotherapies investigated for their efficacy are cytokine therapies and immune checkpoint inhibitors. Cytokine therapies use cytokines (substances made by immune cells) to help the body fight cancer, infection, or other diseases. Immune checkpoint inhibitors block specific proteins binding with their partner proteins, causing the body’s own immune cells to kill cancer cells. Clinical data suggests these techniques can be combined safely, causing synergistic outcomes in antitumour response.
This study will determine if a combination therapy of both the study medication, an investigational cytokine therapy called SOT101, and an immune checkpoint inhibitor, pembrolizumab, can reduce tumour size, and produce a synergistic response.
SOT101 is an engineered fusion protein created through the joining of two or more genes that would usually create separate proteins. SOT101 biological activity comes from the IL-15 component which acts as a pleiotropic cytokine, a cytokine which affects multiple cell types, and plays a critical role in stimulating both innate, the immunity you are born with, and adaptive, immunity which you acquire, immune responses.
The combination therapy, Pembrolizumab, is used to treat cancer due to its ability to help the immune system fight cancer. Pembrolizumab binds to the programmed cell death protein1 (PD-1), causing it to be inhibited. PD-1 binding with its partner protein is a major pathway hijacked by tumours to supress the immune system.
This study is a basket design study, meaning the effectiveness of SOT101 in combination with pembrolizumab in reducing tumour size will be tested over multiple cancer populations.
This study’s designed, organised and funded by the sponsor SOTIO Biotech AG. It’s planned to be carried out in multiple countries across Europe and North America. 320 participants will be enrolled.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0209
Date of REC Opinion
21 Oct 2022
REC opinion
Further Information Favourable Opinion