Cancer Research UK and partners announce new global phase 2 trial in rare adrenal gland cancer

Cancer Research UK, Cytovation and the Norwegian Cancer Society have announced a new multi-national Phase 2 clinical trial (CLARITY; ISRCTN15479264) for people with advanced adrenocortical carcinoma (ACC), a rare and aggressive cancer affecting the adrenal glands.

The trial currently has multiple sites open in the UK with further sites planned across the UK and Europe.

Around 350 people in the UK are diagnosed with ACC every year*. Treatment options are limited, with around 130 people dying from adrenal gland cancer every year in the UK**, underlining an urgent need for new therapies.

For rare cancers, like ACC, where patient populations are smaller, recruitment for clinical trials in a single country can be challenging. Running studies with international partners helps clinical teams to move faster and give more patients with rare cancers access to cutting-edge therapies.

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 (pictured), said: “People living with ACC deserve better treatment options and we are pleased the CLARITY study has reached this exciting stage. We thank our partners, Cytovation and the Norwegian Cancer Society for their ongoing collaboration to help bring us closer to a world where people with rare cancers live longer, better lives, free from the fear of cancer.”

Professor of Experimental Oncology at King’s College London, Consultant Medical Oncologist at Guy’s, St Thomas’ and King’s College Hospitals, and Chief Investigator of the study, Professor Debashis Sarker, said: “Advanced ACC is a rare and highly challenging cancer with very limited treatment options and clinical trials available for patients, leading to poor outcomes. This makes opening a new clinical trial for advanced ACC a very important milestone. We are excited by the scientific rationale and potential of CY-101 and deeply grateful to the patients and clinical research teams participating in this trial.”

CY-101’s development builds on Cytovation’s Phase 1 CICILIA trial, which demonstrated encouraging outcomes in people with solid tumours, including ACC. These results highlight CY-101’s potential to address the specific mechanisms of ACC.

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.”

Cancer treatments are becoming increasingly more targeted which, while increasing efficacy and reducing side effects, narrows the eligibility criteria for taking part in a clinical trial. Cancer Research UK and the Norwegian Cancer Society have worked together since 2023 to broaden access to cutting-edge clinical trials across Europe, with this study being the latest collaboration.

CEO of the Norwegian Cancer Society, Ingrid Stenstadvold Ross, said: “We are excited that our first joint project with Cancer Research UK’s Centre for Drug Development involves a Norwegian innovation, focused on patients with a rare cancer and a substantial unmet need. With the opening of this trial, the treatment is finally reaching patients in the UK and soon also in Norway and other European countries. We are proud to work alongside our partners to develop a new therapy that could offer hope to patients facing aggressive disease.”

Cancer Research UK’s Centre for Drug Development has sponsored, designed and is delivering the Phase 2 CLARITY trial. Cytovation are licensing use of CY-101 for the clinical trial. The Norwegian Cancer Society’s support provides access to the additional resources, patients and sites required for trials in rare diseases. Cancer Research Horizons, Cancer Research UK’s innovation arm, continues to manage the commercial relationship between the three parties.