Highlights
- Radiopharm Theranostics Ltd (ASX:RAD) has gained ethics approval to commence Phase 1 trials for Lu-RAD202, a candidate treatment for HER2-positive breast and gastric cancers.
- The trial will assess the safety and initial clinical activity of 177Lu-labelled RAD 202, targeting HER2-expressing solid tumors.
- Recruitment for the open-label, dose-escalation trial is set to begin across Australia, marking a significant step toward advancing treatment for patients with unmet medical needs.
Radiopharm Theranostics Ltd (ASX:RAD) has achieved ethics approval from the Belberry Human Research Ethics Committee (HREC) to initiate its Phase 1 clinical trial for Lu-RAD202. This development marks a pivotal milestone in the company’s journey toward providing innovative therapeutic solutions for HER2-positive cancers.
The Phase 1 trial is designed to evaluate both the safety and initial clinical activity of 177Lu-labelled RAD 202 in treating solid tumors that express the human epidermal growth factor receptor 2 (HER2). HER2 is a transmembrane tyrosine kinase receptor associated with tumor growth and survival and is frequently overexpressed in cancers such as breast, gastric, pancreatic, bladder, and gynecological tumors.
Details of the Lu-RAD202 Candidate
Lu-RAD202, a single-domain monoclonal antibody (sdAb), specifically targets HER2. The candidate aims to address a critical treatment gap for HER2-positive metastatic cancer patients who are either refractory to or unable to tolerate existing therapies.
The trial is an open-label, dose-escalation study, and recruitment will be conducted across multiple sites in Australia. This approach is expected to provide valuable data on dosage parameters and the candidate's potential effectiveness.
CEO Commentary on the Trial’s Significance
Radiopharm Theranostics’ CEO and managing director, Riccardo Canevari, expressed confidence in the program's progress. Canevari highlighted the potential of RAD 202 to deliver improved clinical outcomes for patients with advanced HER2-positive cancers while potentially preserving their quality of life.
The initiation of this trial represents an essential step forward in addressing the unmet needs of patients with HER2-positive tumors. Radiopharm Theranostics continues to make strides in advancing its pipeline of innovative treatments, aiming to redefine therapeutic standards in oncology.
Bottomline
The ethics approval for Lu-RAD202's Phase 1 trial underscores the progress Radiopharm Theranostics Ltd is making in the development of cutting-edge oncology treatments. As recruitment begins in Australia, the trial will provide critical insights into the potential of Lu-RAD202 to transform outcomes for patients with HER2-positive metastatic cancers.