PAnTHA study: PSMA-targeted Actinium-225-Trillium FiH study in Advance
Research type
Research Study
Full title
A Phase 1 open-label, first-in-human, multi-center study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of 225Ac-PSMA-Trillium in participants with advanced metastatic castration-resistant prostate cancer (mCRPC)
IRAS ID
1009082
Contact name
Christine Blythe
Contact email
Sponsor organisation
Bayer Consumer Care AG
Research summary
The study treatment 225Ac-PSMA-Trillium (or BAY 3563254) is a new type of treatment under development for men with mCRPC who have already received available treatments or have few treatment options available. It works by binding to a protein on the surface of the cancer cells called prostate specific membrane antigen (PSMA) and giving off radiation that can damage cancer cells and stop them from growing. Participants in this study will take the study treatment 225Ac-PSMA-Trillium once in a period of 6 weeks called a cycle. Each participant will have a maximum of 4 of these treatment cycles. Each participant will be in the study for up to nearly six years, including a first test (screening) phase of a maximum of 30 days, up to 9 months of treatment depending on the participant’s benefit, and a follow-up phase of 60 months after the end of treatment. In addition, a sub study will gather information on the distribution of the study treatment in the body, the proportion that binds to the cancer cells, and the resulting radiation at the tumour site. During the study, the study team will do physical examinations, check vital signs such as blood pressure, heart rate, and body temperature, take blood, and urine samples, examine heart health using echocardiogram and electrocardiogram, take tumour samples, track 225Ac-PSMA-Trillium in the body using gamma imaging, check the tumour status using PET (positron emission tomography), CT (computed tomography) or MRI (magnetic resonance imaging) and bone scans, and ask questions about the impact of the disease on the participants’ wellbeing and activities of daily life (Eastern Cooperative Oncology Group Performance status and a questionnaire regarding experiences of mouth dryness).
REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0172
Date of REC Opinion
4 Apr 2024
REC opinion
Further Information Favourable Opinion