In short
REGN10597 is an investigational immunotherapy being studied in adults with advanced solid tumours, including melanoma and clear-cell renal-cell carcinoma (ccRCC). A first-in-human Phase 1/2 trial (NCT06413680) is currently authorised and plans to enrol 233 participants. The study will test REGN10597 alone and in combination with cemiplimab, an approved anti-PD-1 antibody, to assess safety and preliminary anti-tumour activity.
Key points
- REGN10597 is an investigational immunotherapy for advanced solid tumours.
- The first-in-human trial is Phase 1/2 and plans to enrol 233 participants.
- The study tests REGN10597 alone and in combination with cemiplimab.
- Trial status in the EU registry is Authorised.
- Key conditions studied include melanoma and clear-cell renal-cell carcinoma.
- The primary outcomes measure safety and objective response rate.
What is REGN10597?
REGN10597 is an investigational antibody-based medicine. Its full name describes it as an IgG4 antibody fragment against programmed cell death protein 1 (PD-1) fused with interleukin-2 (IL-2) and an antibody fragment against the interleukin-2 receptor subunit alpha. This means the substance combines parts that target PD-1 and the IL-2 receptor in a single molecule. It is not yet authorised as a medicine and is being studied for the first time in humans.
How does REGN10597 work?
REGN10597 is designed to act on two parts of the immune system. The anti-PD-1 part blocks a signal that cancer cells use to switch off immune cells. The IL-2 part is fused to the molecule and is intended to activate immune cells, while the antibody fragment against the IL-2 receptor subunit alpha is meant to direct this activation. The exact mechanism is being investigated in the first-in-human trial.
Which conditions is it studied for?
- Advanced solid tumours — cancers that have spread from where they started to other parts of the body.
- Melanoma — a type of skin cancer that can spread to other organs.
- Clear-cell renal-cell carcinoma (ccRCC) — the most common type of kidney cancer.
How is REGN10597 given?
In the clinical trial, REGN10597 is given by intravenous infusion, which means it is delivered directly into a vein. The trial also uses cemiplimab (LIBTAYO), which is given as a 350 mg concentrate for solution for infusion by intravenous infusion.
What do the clinical trials show?
One clinical trial is currently authorised in the EU registry. It is a Phase 1/2, first-in-human study in adults with advanced solid tumours, including melanoma and clear-cell renal-cell carcinoma. The trial plans to enrol 233 participants.
The study has two parts. The dose escalation phase is conducted only in the United States and evaluates the safety of REGN10597 alone and in combination with cemiplimab. The dose expansion phase is conducted globally and assesses preliminary anti-tumour activity of REGN10597 alone and in combination with cemiplimab.
The primary outcomes include the incidence of dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. The study also measures the objective response rate (ORR), which is the proportion of participants whose tumours shrink or disappear according to RECIST 1.1 criteria.