FDA Agreement Enables U.S. Expansion of Telix’s ProstACT Phase 3 Part 2 Trial
TLX•Telix Pharmaceuticals secured FDA agreement on the Part 2 protocol of its ProstACT Global Phase 3 trial, enabling U.S. enrollment in three randomized standard-of-care cohorts. The FDA confirmed Part 1 safety data support progression to two 177Lu rosopatamab tetraxetan doses 14 days apart with abiraterone, enzalutamide or docetaxel.
1. FDA Aligns with Telix on Part 2 Trial Protocol
Telix announced that a Type B meeting with the FDA concluded successfully, with the agency agreeing that Part 1 safety and dosimetry data justify U.S. progression into Part 2 of the ProstACT Global Phase 3 study. FDA and Telix also aligned on the clinical protocol, statistical analysis plan and ongoing safety monitoring framework for the randomized cohort.
2. Part 2 Design and Therapeutic Regimen
Part 2 is a 2:1 randomized cohort targeting approximately 490 metastatic castration-resistant prostate cancer patients. Participants will receive two doses of lutetium-177 rosopatamab tetraxetan administered 14 days apart, each combined with one of three standard-of-care therapies: abiraterone, enzalutamide or docetaxel.
3. Enrollment Expansion and Next Steps
Recruitment for Part 2 continues in jurisdictions with regulatory approval, and Telix plans to submit an IND amendment to initiate U.S. enrollment. This IND amendment will align with a pending European submission, aiming to standardize global trial execution and maintain strong enrollment momentum.
