177Lu-rosopatamab tetraxetan (TLX591) / Telix, BZL Biologics, China Grand Pharma - LARVOL DELTA

ProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus standard of care vs standard of care alone in patients with metastatic castration-resistant prostate cancer (ESMO 2025) - No abstract available

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ProstACT Global: A Phase 3 Study of Lutetium (Lu177) Rosopatamab Tetraxetan plus Standard of Care vs. Standard of Care Alone in Patients with Metastatic Castration-Resistant Prostate Cancer (ASTRO 2025) - No abstract available

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus standard of care vs standard of care alone in patients with metastatic castration-resistant prostate cancer (EANM 2025) - No abstract available

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination with Standard of Care Versus Standard of Care Alone in Patients with Prostate-Specific Membrane Antigen (SNMMI 2025) - P3 | "In Part 1, patients will be divided into 3 groups (n=10 each) to receive 2 single intravenous (IV) injections of 76 milicuries (mCi) each, 14 days apart, of 177Lu-rosopatamab with best standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to fully characterize biodistribution and safety profiles of 177Lu-DOTA-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes... Effective treatment options for mCRPC with favorable safety and tolerability profiles continue to be an unmet need. Combining the advantages of targeted radiotherapy and immunotherapy, along with proven patient selection capabilities of 68Ga-PSMA-11 PET, provides reasonable justification for further evaluation of 177Lu-rosopatamab in a..."

Clinical • Combination therapy • P3 data • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination with Standard of Care Versus Standard of Care Alone in Patients with Prostate-Specific Membrane Antigen (SNMMI 2025) - P3 | "In Part 1, patients will be divided into 3 groups (n=10 each) to receive 2 single intravenous (IV) injections of 76 milicuries (mCi) each, 14 days apart, of 177Lu-rosopatamab with best standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to fully characterize biodistribution and safety profiles of 177Lu-DOTA-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes... Effective treatment options for mCRPC with favorable safety and tolerability profiles continue to be an unmet need. Combining the advantages of targeted radiotherapy and immunotherapy, along with proven patient selection capabilities of 68Ga-PSMA-11 PET, provides reasonable justification for further evaluation of 177Lu-rosopatamab in a..."

Clinical • Combination therapy • P3 data • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

CONVERGE-01: Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA-Positive Castration-Resistant Prostate Cancer (SNMMI 2025) - "(No results as per Trials in Progress format)."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CONVERGE-01: Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA-Positive Castration-Resistant Prostate Cancer (SNMMI 2025) - "(No results as per Trials in Progress format)."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Telix Theranostic Programs and Satellite Symposia on Innovation in PSMA and CAIX Imaging Featured at SNMMI 2025 (Telix Press Release) - "Presentation highlights include the ProstACT Global Phase 3 study of TLX591 in advanced prostate cancer, preclinical data on Telix’s TLX252 alpha therapy candidate in CAIX expressing tumors in combination with DDRIs, and clinical study data on Illuccix impact on decision-making. Two sponsored symposia will highlight innovation in precision diagnostics, the first on CAIX-PET imaging in renal cancer, and the second on Illuccix PSMA-PET imaging in prostate cancer, including Telix’s new PSMA biopsy trial."

Clinical data • Preclinical • Bladder Cancer • Castration-Resistant Prostate Cancer • Kidney Cancer

CUPID (64Cu-TLX592 phase I PK, biodistribution and dosimetry): A proof-of-concept study of TLX592 targeted alpha therapy in prostate cancer. (ASCO 2025) - P1 | " TLX592 blood clearance was more rapid than TLX591 (T½=19.86+1.96, T½=33.65+11.04h, resp.) with similar organ uptake. Preliminary results demonstrate successful proof-of-concept of RADmAb technology, intended for use with therapeutic alpha-emitting radionuclides. Rapid antibody clearance has potential to minimize radiation exposure & augment the safety & tolerability profile of antibody-based therapies. Residence times (mean±SD) MBq.hr.MBq-1."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase 3 study of 177Lu-rosptamab plus standard of care vs. standard of care alone in patients with metastatic castration-resistant prostate cancer (ProstACT Global). (ASCO 2025) - P3 | "Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes. An alpha control and 95% confidence intervals will be used; patients will be substratified between TLX591 + 2nd ARPI or TLX591 + docetaxel. This study is currently enrolling."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

Telix at ANZSNM Annual Scientific Meeting 2025 (PRNewswire) - "Telix Pharmaceuticals Limited...announces a strong presence at the 55th Annual Scientific Meeting of the Australian and New Zealand Society of Nuclear Medicine (ANZSNM ASM 2025), to be held in Melbourne, Australia from 23–25 May 2025....Demonstrating its commitment to development and education in theranostics, Telix presentations include: ProstACT Global Phase 3 study of TLX591 (177Lu-rosopatamab tetraxetan), Telix's first-in-class PSMA targeting radio antibody-drug conjugate (rADC) therapy candidate; STARSTRUCK study of TLX250 (177Lu-girentuximab) in combination with peposertib in patients with carbonic anhydrase IX (CAIX)-expressing solid tumors, and a preclinical evaluation of 225Ac-girentuximab in combination with DNA damage response inhibition..."

Clinical data • Preclinical • Castration-Resistant Prostate Cancer

THE APPLICATION FOR THE GROUP’S GLOBAL INNOVATIVE RDC TLX591 TO JOIN INTERNATIONAL MULTICENTER PHASE III CLINICAL TRIAL IS ACCEPTED BY THE NMPA (HKEXnews) - "The Board is pleased to announce that the Group’s global innovative radionuclide-drug conjugate ('RDC') TLX591 for the treatment of prostate cancer, has recently had its Investigational New Drug (IND) application for inclusion in an international multicenter Phase III clinical trial formally accepted by the the National Medical Products Administration of the People’s Republic of China ('NMPA')....The study is a prospective, randomized, controlled, open-label, international multicenter Phase III clinical trial, planning to enroll over 500 patients across multiple countries, including China, the United States, Australia, and New Zealand."

New P3 trial • Castration-Resistant Prostate Cancer

PROSTACT GLOBAL: A PHASE 3 STUDY OF 177LU-ROSPTAMAB PLUS STANDARD OF CARE VS. STANDARD OF CARE ALONE IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (AUA 2025) - P3 | "SoC will be determined prior to randomization, and a change in planned SoC will not be permitted.Eligible patients must have PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes. An alpha control and 95% confidence intervals will be used; patients will be substratified between TLX591 + 2nd ARPI or TLX591 + docetaxel. This study is currently enrolling."

Clinical • Metastases • P3 data • Cardiovascular • Castration-Resistant Prostate Cancer • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Genito-urinary Cancer • Hematological Disorders • Hepatocellular Cancer • Oncology • Prostate Cancer • Solid Tumor

177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Weill Medical College of Cornell University | Trial completion date: Dec 2025 ➔ May 2026

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

A Phase 3 Study with standard of care with and without 177Lu-rosopatamab (TLX591) for patients with metastatic castration-resistant prostate cancer progressing despite treatment with a novel androgen axis drug (ProstACT GLOBAL) (EAU 2025) - No abstract available

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

EAU 2025: A Phase 3 Study with Standard of Care with and Without 177Lu-Rosopatamab (TLX591) for Patients with Metastatic Castration-Resistant Prostate Cancer Progressing Despite Treatment with a Novel Androgen Axis Drug (ProstACT GLOBAL) (UroToday) - "The ProstACT Global trial is a prospective, open-label Phase 3 study designed to enroll PSMA+ mCRPC patients who have progressed on ARPI (abiraterone, apalutamide, darolutamide, enzalutamide) in either the mCSPC or mCRPC setting. Patients may have received prior docetaxel in the mCSPC setting, provided the last dose was ≥6 months before screening. The study aims to enroll 520 men and is structured in two parts: a dosimetry and safety lead-in phase, followed by a randomized treatment expansion phase."

Clinical protocol • Castration-Resistant Prostate Cancer

Investor Webinar: Telix Therapeutics Urology Showcase and Expert Forum (GlobeNewswire) - "In this education session, Telix and global key opinion leaders will provide an overview on the development of its therapeutic candidates in prostate and kidney cancers: Neeraj Agarwal, MD...will discuss the ProstACT Global Phase 3 trial of TLX591 (177Lu rosopatamab tetraxetan), Telix’s lead radio antibody-drug conjugate (rADC) therapy candidate in prostate cancer; Eric Jonasch, MD...will discuss the STARLITE studies of TLX250 (177Lu girentuximab) in combination with immunotherapy, in clear cell renal cell carcinoma; Rodney Hicks, MD...will discuss TLX592 (64Cu/225Ac RADmAb) and the role of targeted alpha therapies in the treatment of prostate cancer."

Clinical • Genito-urinary Cancer • Prostate Cancer • Renal Cell Carcinoma

Recruitment Spotlight: Phase 3 Clinical Trial of Novel Prostate Cancer Radiopharmaceutical Now Active in Miami (GlobeNewswire) - "Telix Pharmaceuticals Limited...announces that the Biogenix Molecular Research Center in Miami, FL, is recruiting and dosing patients in the ProstACT Global Phase 3 trial of TLX591 for patients with advanced prostate cancer, as part of a wider United States (U.S.) roll-out....This month, Biogenix Molecular Research Center successfully administered two doses of TLX591, 14 days apart, to a local Miami-based patient, and continues to recruit eligible patients in the Miami area."

Trial status • Prostate Cancer

Telix to Showcase Urology Pipeline at Upcoming ASCO Genitourinary Cancers Symposium (ASCO GU 2025) (GlobeNewswire) - "Telix Pharmaceuticals Limited...today announces presentations featuring the Company’s late-stage and next generation therapeutic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2025) to be held in San Francisco, CA (US) from 13 – 15 February 2025...'For the first time at a medical congress, preliminary data will be presented from the CUPID study of TLX592, which was successful in demonstrating clinical proof-of-concept of Telix’s alpha therapy candidate for prostate cancer.' ProstACT GLOBAL, the first Phase 3 trial to evaluate Telix’s lead rADC therapy candidate, TLX591...will be highlighted during a ‘Trials In Progress’ presentation. In kidney cancer, Principal Investigators of the STARLITE-1 and -2 investigator-initiated trials will provide an update on design and status of these trials in progress."

P1 data • Trial status • Castration-Resistant Prostate Cancer • Kidney Cancer • Prostate Cancer

CUPID (64Cu-TLX592 phase I PK, biodistribution and dosimetry): A proof-of-concept study of TLX592-targeted alpha therapy in prostate cancer. (ASCO-GU 2025) - P1 | " TLX592 blood clearance was more rapid than TLX591 (T½=19.86+1.96, T½=33.65+11.04h, resp.) with similar organ uptake. Preliminary results demonstrate successful proof-of-concept of RADmAb technology, intended for use with therapeutic alpha-emitting radionuclides. Rapid antibody clearance has potential to minimize radiation exposure & augment the safety & tolerability profile of antibody-based therapies. Residence times (mean±SD) MBq.hr.MBq-1."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ProstACT GLOBAL: A phase 3 study of 177Lu-rosopatamab (TLX591) with and without the best standard of care for patients with PSMA expressing metastatic castration-resistant prostate cancer progressing despite prior treatment with a novel androgen axis drug. (ASCO-GU 2025) - P3 | "In Part 1, patients will be divided into 3 groups (n=10 each) to receive 2 single intravenous (IV) injections of 76 millicuries (mCi) each, 14 days apart, of 177Lu-rosopatamab with best standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to fully characterize biodistribution and safety profiles of 177Lu-DOTA-rosopatamab + SoC combinations. Key secondary endpoint is OS. Additional secondary endpoints include 5-year overall survival, tumor objective response rate, time to symptomatic skeletal event, and health-related quality of life."

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CONVERGE-01: Dosimetry, randomized dose optimization, dose escalation, and efficacy of ac-225 rosopatamab tetraxetan in participants with PSMA-positive castration-resistant prostate cancer. (ASCO-GU 2025) - P2 | "Exploratory endpoints include: rPFS, ORR, and DOR via RECIST v1.1 (PCWG3-modified where appropriate), genomic and imaging biomarker nomination. Enrollment began in August 2024."

Clinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ASCO GU 2025: ProstACT GLOBAL: A Phase 3 Study of 177Lu-Rosopatamab (TLX591) with and Without the Best Standard of Care for Patients with PSMA Expressing mCRPC Progressing Despite Prior Treatment with a Novel Androgen Axis Drug (UroToday) - "This multinational, multicenter, prospective, randomized, open-label phase 3 study will have two parts: a dosimetry and safety lead-in (n = 30) and a randomized treatment expansion (n = 490). In Part 1, patients will be divided into three groups (n = 10 each) to receive two single IV injections of 76 millicuries (mCi) each, 14 days apart, of 177Lu-rosopatamab with best standard of care combinations with abiraterone, enzalutamide, or docetaxel to fully characterize biodistribution and safety profiles of 177Lu-DOTA-rosopatamab + standard of care combinations. Standard of care received will be determined prior to treatment with 177Lu-rosopatamab."

Clinical protocol • Prostate Cancer

DNA-Dependent Protein Kinase Inhibitor Peposertib Enhances Efficacy of 177Lu-Based Radioimmunotherapy in Preclinical Models of Prostate and Renal Cell Carcinoma. (PubMed, J Nucl Med) - " 177Lu-DOTA-girentuximab (targeting carbonic anhydrase IX) or 177Lu-DOTA-rosopatamab (targeting prostate-specific membrane antigen) was used to deliver β-radiation to tumors via a single intravenous dose (3 or 6 MBq) in mice bearing SK-RC-52 RCC or LNCaP prostate cancer xenografts, respectively. Our findings suggest a synergistic effect between peposertib and 177Lu-based radioimmunotherapy, wherein peposertib enhanced the efficacy of radioimmunotherapy. This synergy indicates the potential to reduce the necessary dose of radioimmunotherapy for effective cancer treatment."

Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • CA9

External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET) (clinicaltrials.gov) - P2 | N=5 | Completed | Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited | Active, not recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Mar 2024

Metastases • Trial completion • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor