Radiopharm Theranostics Advances RAD 402 into Phase 1 Trial for Advanced Prostate Cancer
Event summary
- Radiopharm Theranostics dosed the first patient in its Phase 1 trial of RAD 402, a monoclonal antibody targeting KLK3 radiolabeled with Terbium 161, for advanced prostate cancer.
- The Phase 1 trial (NCT07259213) aims to assess safety, tolerability, and preliminary clinical activity, with data from the first two dose levels expected in the second half of 2026.
- Preclinical studies showed strong tumor targeting with minimal bone/marrow uptake and expected hepatic clearance.
- RAD 402 is designed to selectively target KLK3-expressing tumors, leveraging the dual emission of Tb161.
The big picture
Radiopharm Theranostics is advancing its pipeline in the competitive radiopharmaceutical space, targeting high-unmet needs in oncology. The Phase 1 trial of RAD 402 represents a strategic push into prostate cancer, an area with significant therapeutic challenges. The company's ability to differentiate its radiolabeled monoclonal antibody approach will be key to its long-term success.
What we're watching
- Clinical Progress
- The pace at which Radiopharm Theranostics can advance RAD 402 through Phase 1 and into Phase 2 will determine its competitive positioning in the prostate cancer radiopharmaceutical space.
- Data Readouts
- Whether the preliminary data from the first two dose levels in 2H 2026 will validate the preclinical promise of strong tumor targeting and minimal off-target effects.
- Strategic Partnerships
- How the collaboration with TerThera and Cyclotek will impact the supply and distribution of Tb161, a critical component for RAD 402's development.