Radiopharm advances RAD202 to Cohort 4 after positive safety committee review
Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX) has received a positive recommendation from its Data Safety and Monitoring Committee (DSMC) to advance its radiotherapeutic asset 177Lu-RAD202 to the next dose level in the Phase 1 ‘HEAT’ clinical trial.
The recommendation clears the way for the trial to progress to 180mCi in Cohort 4, stepping up from the 130mCi dose level announced on 8 April 2026. The study is evaluating the asset in patients with HER2-positive advanced solid tumors.
The Cohort 3 advancement at 130mCi, cleared by the DSMC on 8 April 2026 following successful completion of Cohort 2 at 75mCi, established the immediate prior dose level from which the current 180mCi escalation steps up.
The decision reflects a favourable safety profile observed to date and green-lights continued evaluation at higher dose levels in the Phase 1 study (NCT06824155).
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What the DSMC decision means for the HEAT trial
The Phase 1 ‘HEAT’ study is a dose-escalation trial currently being conducted at clinical centres across Australia.
The DSMC plays a defined oversight role in the trial:
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A multidisciplinary committee that conducts detailed reviews of study data
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Discusses potential safety events
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Provides recommendations regarding trial continuation
Its positive recommendation to advance to the next dose level of 180mCi supports the safety data generated so far.
CEO Commentary
“Advancing RAD202 into Cohort 4 marks a significant step forward in the development of one of our most promising therapeutic candidates,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “The DSMC’s recommendation supports the favorable safety profile observed to date and allows us to continue evaluating higher dose levels in patients with HER2-positive advanced solid tumors. As we execute on our clinical development strategy, we remain focused on unlocking the full potential of RAD202 and generating meaningful data that could support a differentiated radiotherapeutic option for HER2-positive patients in need of new treatment alternatives.”
Understanding RAD202 and the HER2 target
RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets HER2 expression in advanced solid tumors.
HER2 is overexpressed in breast cancer and several other solid tumors, and the company describes it as a validated target in oncology.
In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and showed positive safety and biodistribution.
| Attribute | Detail |
|---|---|
| Asset | 177Lu-RAD202 |
| Modality | Single-domain monoclonal antibody (sdAb) |
| Target | HER2-positive advanced solid tumors |
| Current trial | Phase 1 ‘HEAT’ (Cohort 4, 180mCi) |
| Prior evidence | Proof-of-concept in 10 HER2+ breast cancer patients |
Where RAD202 fits in Radiopharm’s broader pipeline
The RAD202 update sits within a wider clinical program that includes one Phase 2 and five Phase 1 trials across lung, breast, prostate and brain cancers. The company’s platform spans peptides, small molecules and monoclonal antibodies for use in cancer.
The 177Lu-BetaBart program, which dosed its first patient in a Phase 1/2a trial targeting B7-H3-expressing solid tumours across ten cancer types, illustrates the breadth of the radiotherapeutic platform sitting alongside RAD202 in Radiopharm’s clinical portfolio.
What comes next
The HEAT trial will continue its dose-escalation evaluation at the 180mCi level across Australian clinical sites. Management has stated it remains focused on generating meaningful data that could support a differentiated radiotherapeutic option for HER2-positive patients.
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