A Phase II Trial of CY-101 in Adrenocortical Carcinoma (CLARITY)
Research type
Research Study
Full title
A Cancer Research UK Phase II Trial of CY-101 Given via Intratumoural Administration in Locally Advanced or Metastatic Adrenocortical Carcinoma (CLARITY)
IRAS ID
1012105
Contact name
Damian Janecki
Contact email
Sponsor organisation
Cancer Research UK
ISRCTN Number
ISRCTN15479264
Research summary
In this clinical trial, researchers are testing a drug called CY-101. CY-101 is a type of drug called a peptide. CY-101 works in two ways: 1) It binds to cancer cells and destroys their outer layer (membrane), leading to the killing of the cells; 2) It enters into the cancer cells and activates a protein called Axin2, which in turn reduces the levels of another protein that helps cancer cells to survive, called β-catenin. Both these ways of working trigger the body’s immune system to kill more cancer cells, both in the treated tumour and tumours that have spread elsewhere in the body. Due to the small size and nature of CY-101, the only way to give the drug and get it close to cancer cells is to inject it directly into the tumour lesions (an area where cancer is present); this is called an intratumoural injection. In most cases, this will be under the guidance of an ultrasound or CT scan.
CY-101 has been tested in clinical trials before and now researchers want to find out if it will be effective in treating people with Adrenocortical Carcinoma (ACC). This clinical trial is in 2 phases. In Phase 2A (dose optimisation), 2 different doses of CY-101 will be tested to decide which is the best dose to give to a larger number of participants with ACC in Phase 2B. Phase 2B (dose expansion) of the trial will help us get more information on whether CY-101 is effective in treating people with ACC.
The main aims of the trial are to find out the best dose of CY-101 that can be given safely to people with ACC; more about the potential side effects of CY-101; what happens to CY-101 inside the body; and whether CY-101 is effective in treating people with ACC.
The trial aims to recruit 41 participants with ACC who are aged 16 years and over and have received at least one but no more than two previous lines of treatment for their cancer.REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0815
Date of REC Opinion
16 Dec 2025
REC opinion
Further Information Favourable Opinion