177Lu-RAD202 Dose Doubled to 75mCi Following Positive Safety Review
Radiopharm Theranostics has received a positive safety recommendation to increase the dose of its radiotherapeutic 177Lu-RAD202 in the Phase 1 HEAT trial for HER2-positive advanced solid tumors, signaling promising early results.
- DSMC approves dose escalation from 40mCi to 75mCi in Phase 1 trial
- Positive safety and pharmacokinetic data from initial 30mCi cohort
- Trial targets HER2-positive advanced solid tumors with radiotherapeutic 177Lu-RAD202
- Data from first two cohorts expected by year-end 2025
- Study conducted across multiple Australian clinical centers
Positive Safety Review Spurs Dose Escalation
Radiopharm Theranostics Limited has announced a significant milestone in its Phase 1 HEAT clinical trial, receiving a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to accelerate dosing of its lead radiotherapeutic candidate, 177Lu-RAD202. The DSMC's endorsement allows the trial to advance directly to a 75mCi dose level, nearly doubling the originally planned 40mCi, reflecting encouraging early safety and pharmacokinetic data.
Targeting HER2-Positive Advanced Solid Tumors
177Lu-RAD202 is a novel radiopharmaceutical designed to target HER2-positive advanced solid tumors, a category that includes aggressive breast cancers and other difficult-to-treat malignancies. HER2 overexpression is a well-established driver of tumor growth, and Radiopharm’s approach leverages a proprietary single domain monoclonal antibody to deliver targeted radiation therapy directly to cancer cells, potentially improving efficacy while limiting systemic side effects.
Trial Progress and Next Steps
The Phase 1 HEAT trial began dosing patients in June 2025, with the first cohort receiving 30mCi of 177Lu-RAD202. Following a thorough review, the DSMC confirmed positive safety signals and favorable pharmacokinetics, allowing the trial to proceed without modifications. Enrollment for the second cohort at the higher 75mCi dose is expected to commence in the fourth quarter of 2025, with data from the first two cohorts anticipated by year-end.
Implications for Radiopharm’s Pipeline
This accelerated dose escalation marks a pivotal step in Radiopharm’s clinical development pathway, bringing the company closer to identifying an optimal dose for Phase 2 trials. CEO Riccardo Canevari highlighted the strong interest in new therapies for HER2-positive cancers and expressed optimism about RAD202’s potential to address this unmet medical need. The company’s broader pipeline includes multiple clinical-stage programs targeting various solid tumors, underscoring its commitment to innovative oncology solutions.
Looking Ahead
With the trial advancing swiftly and safety data supporting higher dosing, Radiopharm Theranostics is well-positioned to maintain momentum in its clinical programs. The upcoming data releases will be closely watched by investors and the oncology community alike, as they will provide critical insights into the therapeutic promise of 177Lu-RAD202.
Bottom Line?
Radiopharm’s dose escalation signals growing confidence in RAD202’s safety profile, setting the stage for pivotal data later this year.
Questions in the middle?
- Will the higher 75mCi dose maintain the favorable safety profile observed at 30mCi?
- How will RAD202’s efficacy signals evolve as dosing increases in subsequent cohorts?
- What competitive advantages might RAD202 hold compared to other HER2-targeted therapies in development?
