Radiopharm Theranostics Completes RAD 101 Phase 2b, Advances RAD 202 and First-in-Human Trials
Radiopharm Theranostics completed enrollment in its 30-patient Phase 2b RAD 101 imaging trial, reporting 90% MRI concordance (18/20) and a supply agreement with Siemens Healthineers. Radiopharm advanced RAD 202’s Phase 0/1 trial with DSMC clearance to 130 mCi dosing and initiated first-in-human studies for radiotherapeutics RV-01 and RAD 402.
1. RAD 101 Phase 2b Completion and Interim Data
Radiopharm completed enrollment of 30 patients in its single-arm Phase 2b RAD 101 imaging trial targeting recurrent brain metastases, reporting 90% concordance (18/20) with MRI as the primary endpoint. The molecule holds FDA Fast Track designation and the company secured a supply agreement with Siemens Healthineers to radiolabel and distribute RAD 101.
2. RAD 202 Phase 0/1 Trial Advancement
In the Phase 0/1 'HEAT' trial for RAD 202—an HER2-targeted nanobody—the compound demonstrated meaningful tumor uptake, a favorable safety profile with no dose-limiting toxicities and expected organ dosimetry. Following a positive Data Safety Monitoring Committee recommendation, Radiopharm will escalate dosing to 130 mCi in Cohort 3, with combined Cohort 2 and 3 data due mid-2026.
3. First-in-Human Trials Initiation
Radiopharm launched first-in-human clinical studies for RV-01, a B7H3-targeted radiotherapeutic developed in collaboration with MD Anderson, and RAD 402 in advanced prostate cancer. These Phase 1 trials will assess safety, biodistribution, pharmacokinetics and dosimetry, marking the expansion of Radiopharm’s therapeutic pipeline in oncology.