On April 21, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that safety and tolerability data from the ProstACT Global Phase 3 study (Part 1) will be presented as a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
ProstACT Global is an international, multi-center, Phase 3 trial evaluating Telix’s lead prostate-specific membrane antigen (PSMA) targeted lutetium radio antibody-drug conjugate (rADC) therapy, TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan), in combination with standard of care (SoC) versus SoC alone. The study is designed to reflect real-world global clinical practice with the aim to support broad geographic adoption in the evolving prostate cancer treatment landscape.
Part 1 of the trial is a safety and dosimetry lead-in, assessing the tolerability, biodistribution, and radiation dose profile of TLX591-Tx when administered in combination with SoC in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
The selection of this abstract as a late-breaking oral presentation at ASCO (Free ASCO Whitepaper) underscores the potential clinical significance of the ProstACT Global study and Telix’s continued leadership in advancing next-generation radiopharmaceutical therapies for prostate cancer.
Presentation details are as follows:
Title: Safety and dosimetry of 177Lu-rosopatamab tetraxetan plus SoC in patients with metastatic castration-resistant prostate cancer: Preliminary results from Part 1 of Phase 3 ProstACT Global study.
Presenting Author: Pedro C. Barata, MD, MSc, University Hospitals Seidman Cancer Center, Cleveland, OH.
Abstract Number: LBA5009.
Date, Time and Location: June 1, 2026, 3:12 p.m. – 3:24 p.m. CDT, Arie Crown Theater
Session Type and Title: Clinical Science Symposium – Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer
Late-breaking abstracts will be made publicly available at 7:00 a.m. CDT (8:00 a.m. EDT) on the day of presentation. Additional information can be found at www.asco.org
About ProstAct Global
ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multi-center trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET1 imaging agent (such as Illuccix, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one androgen receptor pathway inhibitor (ARPI).
The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies2, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys3. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs4.
Additional information on the Phase 3 ProstACT Global study can be found at: View Source
TLX591-Tx has not received a marketing authorization in any jurisdiction.
(Press release, Telix Pharmaceuticals, APR 21, 2026, View Source [SID1234664655])