Full Press Release Details
Theranostics advances to Cohort 3 in 177Lu-RAD202 Phase 1 Dose Escalating Clinical Trial
Sydney, Australia - 8 April 2026 -
Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical
company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that it
has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic
asset, 177Lu-RAD202 (RAD202), to the next dose level of 130mCi in the Phase 1 HEAT' clinical trial in patients with Human
Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors1.
The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides
recommendations regarding trial continuation.
"We are encouraged by the rapid progress of the Phase 1 HEAT'
trial of RAD202, as it underscores the favorable safety profile, allowing us to accelerate the dose escalation from Cohort 2 to Cohort
3." said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Considering the current progress and the
strong execution, we remain on track to complete the Phase 1 dose escalation by the end of 2026."
The Phase 1 HEAT' study is currently being conducted at
clinical centers across Australia. The announcement of the previous dose level in this study of 75mCi was released on 1 October 2025.
RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that
targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast
cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive
breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company
developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high
unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated
platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one
Phase 2 and five Phase 1 trials in a variety of solid tumor cancers including lung, breast, prostate and brain. Learn more at radiopharmtheranostics.com.
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia
Authorized on behalf of the Radiopharm
Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
CEO & Managing Director
Precision AQ (formerly Stern IR)
Follow Radiopharm Theranostics:
Website - https://radiopharmtheranostics.com/
InvestorHub - https://investorhub.radiopharmtheranostics.com/
Radiopharm Theranostics
Suite 1, Level 3, 62 Lygon Street, Carlton South VIC 3053 Australia