Radiopharm Theranostics Advances 177Lu-RAD202 to 130 mCi after Positive Phase 1 Safety Data
Radiopharm Theranostics reported 177Lu-RAD202 achieved significant tumor uptake and no dose-limiting toxicities in the 30 mCi cohort of its Phase 0/1 trial involving three heavily pretreated HER2-positive patients. The Data Safety and Monitoring Committee approved escalation to 130 mCi, supporting further evaluation of safety and antitumor activity.
1. Phase 0/1 Trial Design
The HEAT trial is a first-in-human, open-label Phase 0/1 study evaluating 177Lu-RAD202 in patients with HER2-positive locally advanced or metastatic solid tumors. Phase 0 assesses biodistribution, pharmacokinetics and dosimetry with imaging doses, while Phase 1 uses dose escalation to determine safety and recommended Phase 2 dose.
2. Initial Safety and Uptake Findings
In the initial 30 mCi cohort of three heavily pretreated HER2-positive breast and urothelial cancer patients, 177Lu-RAD202 demonstrated meaningful tumor uptake, particularly in breast lesions, and was generally well tolerated with only Grade 1–2 adverse events and no dose-limiting toxicities or treatment discontinuations.
3. Dose Escalation and Next Steps
The Data Safety and Monitoring Committee approved advancement to a 130 mCi dose level after confirming organ-level absorbed doses were within expected, acceptable ranges. The company will evaluate safety, biodistribution and signs of antitumor activity at this higher dose to guide further development.