Telix to Present Safety and Dosimetry Data from 36-Patient Phase 3 Trial at ASCO
ProstACT Global Phase 3 Part 1 safety and dosimetry data from 36 mCRPC patients treated with TLX591-Tx plus standard of care will be presented as a late-breaking oral at ASCO 2026 on June 1. TLX591-Tx, a lutetium-177 PSMA-targeted rADC, showed hepatic clearance limiting kidney toxicity and minimal salivary uptake in the lead-in cohort.
1. ASCO 2026 Late-Breaking Oral Presentation
Telix will deliver an oral presentation of ProstACT Global Phase 3 Part 1 data on June 1, 3:12–3:24 p.m. CDT at the Arie Crown Theater during the Clinical Science Symposium “Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer.” The late-breaking abstract (LBA5009) covers safety, tolerability and biodistribution of TLX591-Tx plus standard of care in metastatic castration-resistant prostate cancer.
2. Trial Design and Patient Cohort
Part 1 enrolled 36 PSMA-positive mCRPC patients in a safety and dosimetry lead-in to assess TLX591-Tx in combination with standard of care versus standard of care alone. Key endpoints include tolerability, biodistribution and radiation dose profile to inform dosing for the randomized 2:1 global expansion aimed at 490 patients.
3. TLX591-Tx Pharmacology and Safety Profile
TLX591-Tx is a PSMA-targeted radio antibody-drug conjugate labeled with lutetium-177 and cleared primarily via the liver, reducing renal radiation exposure. In the lead-in cohort, minimal salivary and lacrimal gland uptake was observed, suggesting a lower risk of dry mouth and dry eye compared with small-molecule radioligand therapies.