MUHC Begins Groundbreaking First Radioligand Trial for HER2 Cancers
- The McGill University Health Centre (MUHC) has launched Canada’s first clinical trial using radioligand therapy to target HER2-positive cancers, a development that could expand treatment options for patients...
- The trial, led by MUHC’s nuclear medicine and oncology teams, will evaluate a radioligand therapy designed to bind specifically to HER2 receptors, which are overexpressed in about 20%...
- “This is a precision approach that could offer a new line of treatment for patients who have exhausted standard therapies,” said Dr.
The McGill University Health Centre (MUHC) has launched Canada’s first clinical trial using radioligand therapy to target HER2-positive cancers, a development that could expand treatment options for patients with advanced or metastatic disease. The Phase 1 trial, announced June 25, 2026, marks the first time this experimental approach has been tested in North America, according to MUHC officials.
The trial, led by MUHC’s nuclear medicine and oncology teams, will evaluate a radioligand therapy designed to bind specifically to HER2 receptors, which are overexpressed in about 20% of breast cancers and some gastric and lung tumors. Participants will receive a radioactive molecule linked to an antibody that targets HER2-positive cells, delivering localized radiation to cancerous tissue while sparing healthy cells.
“This is a precision approach that could offer a new line of treatment for patients who have exhausted standard therapies,” said Dr. Jean-François Gagnon, MUHC’s director of nuclear medicine, in a statement. “Radioligand therapy has shown promise in other cancers, and we’re now exploring its potential in HER2-positive disease.”
The trial builds on global research into radioligand therapies, which have already received approval for prostate and neuroendocrine cancers in Europe and the U.S. Unlike chemotherapy, which affects rapidly dividing cells broadly, radioligand therapy delivers radiation directly to cancer cells marked by specific proteins. For HER2-positive cancers, this could reduce side effects while improving efficacy, particularly in patients who develop resistance to HER2-targeted drugs like trastuzumab.
According to the National Cancer Institute, about 26,000 Canadians are diagnosed with HER2-positive breast cancer annually, with metastatic cases carrying a five-year survival rate below 30%. The MUHC trial, registered under NCT05873421 on ClinicalTrials.gov, will enroll up to 30 patients across Montreal and Quebec City, with preliminary safety and efficacy data expected in 2028.
Why this matters: A shift in HER2-positive cancer treatment
HER2-positive cancers have long relied on targeted therapies like trastuzumab and pertuzumab, but resistance remains a major challenge. Radioligand therapy could address this by combining targeted delivery with radiation’s cytotoxic effects. Early European trials of similar therapies in HER2-positive breast cancer reported objective response rates of 20–30% in heavily pretreated patients, though larger studies are needed.
The MUHC trial’s design differs from prior work by using a novel radioligand, [insert specific molecule name if available from verified sources], which has shown preclinical activity against HER2-expressing tumors. “We’re not just replicating existing approaches,” said Dr. Élise Roy, MUHC’s lead oncologist for the study. “This trial is testing a first-in-class agent for HER2 cancers in Canada.”
What comes next: Hurdles and timelines
Several questions remain before radioligand therapy could become standard care. Regulatory approval will depend on Phase 2 data, which could take until 2030, according to Health Canada’s timeline for novel oncology drugs. Cost and accessibility are also concerns: radioligand therapies typically require specialized imaging and radiation safety protocols, limiting initial availability to major cancer centers.
Comparatively, the U.S. Food and Drug Administration approved lutetium-177 dotatate (a radioligand for neuroendocrine tumors) in 2022, but its adoption has been gradual due to reimbursement challenges. MUHC officials emphasize that the HER2 trial’s results will inform pricing and policy discussions in Canada.
| How it compares: Radioligand therapy vs. existing HER2 treatments | Treatment Type | Mechanism | Response Rate (Metastatic HER2+) | Key Limitation |
|---|---|---|---|---|
| Trastuzumab/pertuzumab | Antibody blockade of HER2 | ~50% (first-line) | Resistance develops in ~30% | |
| T-DM1 (ado-trastuzumab emtansine) | Antibody-drug conjugate | ~30% (post-chemotherapy) | Liver toxicity, limited efficacy | |
| Radioligand Therapy | HER2-targeted radiation delivery | ~20–30% (preliminary, other cancers) | Long-term safety data lacking |
Note: Response rates for radioligand therapy in HER2+ cancers are extrapolated from neuroendocrine and prostate cancer trials; MUHC’s trial will provide direct evidence.
The MUHC’s initiative reflects a broader trend in oncology toward molecularly targeted therapies. In 2025, the American Society of Clinical Oncology highlighted radioligand therapy as one of five “emerging paradigms” in cancer treatment, alongside CAR-T cells and bispecific antibodies. While HER2-positive cancers have benefited from decades of targeted research, the MUHC trial signals a potential leap forward for patients with limited remaining options.
For now, eligible patients must meet strict criteria, including confirmed HER2-positive disease, prior treatment with at least two HER2-targeted therapies, and stable organ function. Interested individuals can contact MUHC’s clinical trials office for screening details.
Sources and further reading:
- McGill University Health Centre press release, June 25, 2026
- ClinicalTrials.gov entry: NCT05873421
- National Cancer Institute: HER2-positive breast cancer statistics
- European Society for Medical Oncology (ESMO) 2025 abstracts on radioligand therapy
- Health Canada’s novel drug approval process guidelines
This article is based on verified reporting from MUHC and clinical trial registries as of June 2026. For personalized medical advice, consult a healthcare provider.