Radiopharm Theranostics Advances to Cohort 3 in 177Lu-RAD202 Phase 1 Dose Escalating Clinical Trial
Rhea-AI Summary
Radiopharm Theranostics (NASDAQ: RADX) received a positive DSMC recommendation to advance 177Lu-RAD202 to 130mCi (Cohort 3) in the Phase 1 HEAT trial for HER2+ advanced solid tumors.
The study is ongoing at Australian sites, the prior dose level was 75mCi (announced 1 Oct 2025), and management says dose escalation remains on track to complete by end of 2026.
Positive
- DSMC recommended advancement to 130mCi (Cohort 3)
- Favorable safety profile enabled accelerated dose escalation
- On track to complete Phase 1 dose escalation by end of 2026
Negative
- None.
News Market Reaction – RADX
In the Apr 8 session, RADX gained 2.99%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 27 | Phase 1 dosing start | Positive | +0.0% | First patient dosed in Phase 1 trial of RAD 402 for advanced prostate cancer. |
| Mar 24 | Phase 2b interim data | Positive | -10.8% | RAD 101 achieved primary imaging endpoint in 90% of evaluated brain metastasis patients. |
| Feb 24 | Phase 1/2a first dosing | Positive | +1.8% | First patient dosed in Phase 1/2a trial of 177Lu‑BetaBart (RV‑01) radiotherapeutic. |
| Dec 15 | Phase 2b interim data | Positive | +149.5% | RAD 101 interim data showed 92% MRI concordance and strong tumor-targeted PET uptake. |
| Nov 18 | Trial approval | Positive | -4.8% | Ethics approval to initiate First‑In‑Human Phase 1 trial of RAD 402 in prostate cancer. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial news has often been positive operationally but produced mixed price reactions, including both strong rallies and notable selloffs.
Over the last several months, Radiopharm Theranostics has repeatedly highlighted clinical progress across multiple assets. RAD 402 and BetaBart (RV‑01) advanced into first‑in‑human Phase 1 studies, while RAD 101 delivered strong interim imaging data with high PET–MRI concordance and even triggered a 149.53% move on Dec 15, 2025. Other clinical updates around RAD 101 and RAD 402 saw flat or negative reactions. Today’s HEAT trial dose‑escalation news fits this pattern of steady pipeline advancement in early‑stage radiopharmaceutical programs.
Key Terms
data safety and monitoring committee medical
dsmc medical
her2+ medical
human epidermal growth factor receptor 2 medical
radiopharmaceuticals medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Receives Positive Recommendation from Data Safety and Monitoring Committee (DSMC) to progress Phase 1 to the next dose level of 130mCi in patients with HER2+ advanced solid tumors
SYDNEY, April 08, 2026 (GLOBE NEWSWIRE) -- 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.
About 177Lu-RAD202:
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.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
1 clinicaltrials.gov/study/NCT06824155
