MUHC launches world’s first radioligand therapy trial for HER2-positive cancers
The MUHC is the first site in the world to launch a first-in-human Phase I clinical trial evaluating a novel radioligand therapy for HER2-positive cancers, including certain types of breast cancer.
A highly innovative therapeutic approach for HER2-positive cancers, characterized by the presence of the HER2 protein on the surface of cancer cells, is being evaluated for the first time in the world at the McGill University Health Centre (MUHC), with support from the Research Institute of the MUHC (The Institute) and its Centre for Innovative Medicine (CIM). Sponsored by Novartis, this Phase I clinical trial aims to assess the safety and potential of this radioligand therapy in patients with metastatic HER2-positive cancer whose disease has progressed despite available treatments. While breast cancer is most commonly associated with HER2-positive disease, other cancers, including lung, stomach and bladder cancers, may also be HER2-positive. The first patients were enrolled in the trial on June 16.
HER2-positive cancers are generally more aggressive in nature. Although HER2-targeted therapies have significantly improved outcomes over the past several years, some patients develop resistance to available treatments or experience disease progression. When the cancer becomes metastatic and targeted treatment options are exhausted, therapeutic options are currently limited. As the first step in evaluating a new treatment in people, this first-in-human Phase I clinical trial is exploring a new targeted therapeutic approach that could, in time, help expand treatment options for these patients.
“The MUHC is increasingly establishing itself as a leader in the field of radioligand therapy, an area where competition is intense worldwide to secure and conduct these types of clinical trials. Our success is made possible by our state-of-the-art infrastructure, our vision centered on innovation and precision medicine, and the outstanding work of our clinical and research teams,” says Dr. Ramy Saleh, medical oncologist at the Cedars Cancer Centre of the MUHC, Medical Director of Oncology Clinical Trials and Phase I Research Unit at The Institute, and Associate Professor in the Gerald Bronfman Department of Oncology at McGill University.
How does radioligand therapy work?
Unlike chemotherapy, immunotherapy, or conventional radiation therapy, radioligand therapy combines a ligand—a molecule capable of recognizing a specific target on cancer cells—with a radioisotope. This approach delivers radiation directly to tumour cells, wherever they may be in the body. The radiation then damages the DNA of cancer cells with the goal of shrinking tumours while limiting damage to surrounding healthy tissue.
Before receiving the treatment, patients undergo a positron emission tomography (PET) scan to confirm that their tumours express the molecular target being investigated—the HER2 protein. During the scan, a radioactive tracer is used to visualize this target and identify patients who may be eligible for and potentially benefit from the therapy.
A steadfast commitment to advancing clinical research
This clinical trial reflects the MUHC’s commitment to remaining at the forefront of research and contributing to the development of new therapeutic approaches. It also underscores the expertise and infrastructure required to bring leading-edge clinical studies to patients.
“Radioligand therapies rely on seamless collaboration between clinical, research and nuclear medicine teams. Thanks to the dedication of our research technologists and the specialized infrastructure we have developed, we are able to offer patients access to innovative clinical studies such as this one. By combining cutting-edge research with advanced patient care, the MUHC continues to strengthen its position as a leading centre in the rapidly evolving field of theranostics and radioligand therapy,” says Dr. Farzad Abbaspour, Director of the Nuclear Medicine Department at the MUHC.
A key contributor to this success is The Institute’s CIM, a state-of-the-art clinical research facility located at the MUHC’s Glen site. The CIM provides specialized infrastructure, technical platforms and dedicated expertise to support the rapid start-up and conduct of complex clinical trials, including early-phase studies through its dedicated Phase I Research Unit.
“The MUHC is proud to provide patients with access to promising experimental therapies. The expertise of our clinical trial start-up team at the Centre for Innovative Medicine is particularly instrumental in rapidly implementing complex clinical studies. For many patients, the opportunity to participate in a clinical trial represents a source of hope and a chance to contribute to the advancement of medicine. We are deeply grateful for the essential role they play in research that will benefit future generations,” said Dr. Angela Genge, Director of Clinical Research and the CIM at The Institute.
Media contact
Fabienne Landry
Communications coordinator, Research, MUHC
[email protected]