Clinical TrialJul 15, 2026, 04:22 PM
Telix Doses First Patients in Phase 2 OPTIMAL-e Study
AI Summary
Telix Pharmaceuticals announced that the first patients have been dosed in the Phase 2 OPTIMAL-e study evaluating TLX597-Tx for metastatic hormone-sensitive prostate cancer (mHSPC). The single-arm, open-label trial, conducted at St Vincent’s Hospital Sydney, will assess the impact of TLX597-Tx on PSA response rate, aiming to improve both the depth and durability of response. TLX597-Tx is Telix’s next-generation PSMA-targeting small molecule radioligand therapy, designed to enhance efficacy and quality of life in earlier-stage prostate cancer through an individualized, adaptive dosing approach.
Key Highlights
- First patients dosed in OPTIMAL-e Phase 2 study for TLX597-Tx.
- Study evaluates TLX597-Tx for metastatic hormone-sensitive prostate cancer (mHSPC).
- OPTIMAL-e is a single-arm, open-label trial at St Vincent’s Hospital Sydney.
- TLX597-Tx is Telix’s next-generation PSMA-targeting radioligand therapy candidate.
- Study aims to improve PSA response rate, depth, and durability.
- Adaptive dosing strategy based on PSMA-PET imaging and PSA measurements.
- TLX597-Tx has not received marketing authorization in any jurisdiction.
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