Cancer Research UK launches a new Phase 2 clinical trial for people with advanced adrenocortical carcinoma, a rare and aggressive cancer. The study will test the effectiveness and safety of Cytovation’s synthetic peptide therapy, CY-101 (getacatetide). The clinical development of CY-101 is part of a collaboration between Cancer Research UK, Cytovation and the Norwegian Cancer Society.
This randomised trial is for patients with adrenocortical carcinoma (ACC) that has spread despite conventional treatment. The trial has six sites open in the UK (Manchester, Leeds, Liverpool, and in London, Guy’s Hospital, the Royal Marsden, and Imperial College) aiming to recruit 41 patients, with further sites across Europe planned. Participating patients will be allocated to one of two arms trialling two different doses of CY-101.
CY-101 (getacatetide), developed by biotech company Cytovation, is a novel intratumoral peptide immunotherapy designed to convert immune-resistant “cold” tumours (such as ACC) into immune-active “hot” tumours. It does this by stimulating local immune activation directly within the tumour microenvironment, while simultaneously inhibiting the Wnt/β-catenin signalling pathway, a key driver of immunotherapy resistance in cancers such as ACC.
Director of the Centre for Drug Development at Cancer Research UK, Dr Lars Erwig, said:
“People living with ACC deserve better treatment options and we are pleased the CLARITY study has reached this exciting milestone. We thank our partners, Cytovation and the Norwegian Cancer Society for their ongoing collaboration to bring us closer to a world where people with rare cancers live longer, better lives, free from the fear of cancer.”
CEO of Cytovation, Dr Lars Prestegarden, said:
“Reaching this milestone is an important step for patients with ACC, where treatment options remain very limited. The activity we observed in the patients with ACC enrolled in our Phase 1 CICILIA trial gave us strong reason to advance into a dedicated Phase 2 study in this disease. We are grateful to Cancer Research UK and the Norwegian Cancer Society for their commitment to bringing new options to people with rare cancers, and to the patients, families and clinical teams making the CLARITY trial possible.”
The criteria for inclusion in and exclusion from this randomised trial are extensive and available on the CRUK website. We recommend that patients who are interested in participating discuss this trial with their specialist.
AMEND will be following the progress of this trial with great interest and aim to periodically update our ACC community on CLARITY.