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177Lu-rosopatamab tetraxetan (TLX591)
i
Other names: TLX591, ATL101, 177Lu-J591 , lutetium-177-labelled anti-PSMA monoclonal antibody J591, MLN 591RL, ATL-101, 177Lu-TX591, 177Lu-DOTA-rosopatamb, 177Lu-TLX591, ATL 101, MLN591RL, MLN-591RL, TLX-591, TLX 591
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Company:
BZL Biologics, China Grand Pharma, Telix
Drug class:
Beta radiation emitter, PSMA inhibitor
Related drugs:
7ms
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer (clinicaltrials.gov)
P2, N=55, Active, not recruiting, Weill Medical College of Cornell University | Trial completion date: Dec 2025 --> May 2026
Trial completion date
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177Lu-rosopatamab tetraxetan (TLX591)
10ms
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.
Preclinical • Journal
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CA9 (Carbonic anhydrase 9)
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peposertib (M3814) • 177Lu-DOTA-girentuximab (TLX250) • 177Lu-rosopatamab tetraxetan (TLX591) • Rencarex (girentuximab)
12ms
External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET) (clinicaltrials.gov)
P2, N=5, Completed, Telix Pharmaceuticals (Innovations) Pty Limited | Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Mar 2024
Trial completion • Trial completion date • Metastases
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177Lu-rosopatamab tetraxetan (TLX591)
1year
ProstACT-GLOBAL: The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT GLOBAL) (clinicaltrials.gov)
P3, N=430, Recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
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docetaxel • Xtandi (enzalutamide) • abiraterone acetate • 177Lu-rosopatamab tetraxetan (TLX591)
over1year
The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT-GLOBAL) (clinicaltrials.gov)
P3, N=430, Not yet recruiting, Telix Pharmaceuticals (Innovations) Pty Ltd
New P3 trial • Combination therapy • Metastases
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docetaxel • Xtandi (enzalutamide) • abiraterone acetate • 177Lu-rosopatamab tetraxetan (TLX591)
over1year
PROSTACT: The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only (clinicaltrials.gov)
P3, N=392, Recruiting, Telix Pharmaceuticals (Innovations) Pty Ltd | Not yet recruiting --> Recruiting | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Jun 2025 --> Nov 2025
Enrollment open • Trial completion date • Trial primary completion date • Metastases
|
docetaxel • Xtandi (enzalutamide) • 177Lu-rosopatamab tetraxetan (TLX591)
over1year
External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET) (clinicaltrials.gov)
P2, N=5, Active, not recruiting, Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting --> Active, not recruiting | N=50 --> 5 | Trial completion date: Jun 2025 --> Aug 2024
Enrollment closed • Enrollment change • Trial completion date • Combination therapy • Metastases
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177Lu-rosopatamab tetraxetan (TLX591)
over1year
Final results of a phase I/II dose-escalation study of fractionated dose 177 Lu-PSMA-617 for progressive metastatic castration resistant prostate cancer (mCRPC). (ASCO 2024)
29 (58%) with prior >2 ARPI, 29 (58%) with >1 chemo, 14 (28%) with Ra-223, 2 (4%) with 177 Lu-J591... A single-cycle of fractionated-dose 177Lu-PSMA-617 is safe. Despite no pre-selection for PSMA expression, most had PSA decline with favorable PFS and OS compared to historical controls and similar to PSMA-selected targeted radionuclide studies administering multiple cycles in a less dose-intense approach.
P1/2 data • Clinical • Metastases
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FOLH1 (Folate hydrolase 1)
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CELLSEARCH®
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Xofigo (radium Ra-223 dichloride) • 177Lu-rosopatamab tetraxetan (TLX591)
almost2years
ProstACTSelect: 177Lu-DOTA-TLX591 Safety, Biodistribution and Dosimetry Study (clinicaltrials.gov)
P1, N=30, Completed, Telix International Pty Ltd | Recruiting --> Completed | N=50 --> 30 | Trial completion date: Sep 2024 --> Sep 2023 | Trial primary completion date: Mar 2024 --> Sep 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
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FOLH1 expression • FOLH1 positive
|
177Lu-rosopatamab tetraxetan (TLX591)
almost2years
ProstACT GLOBAL: A phase 3 study of best standard of care with and without 177Lu-DOTA-rosopatamab (TLX591) for patients with PSMA expressing metastatic castration-resistant prostate cancer progressing despite prior treatment with a novel androgen axis drug. (ASCO-GU 2024)
Eligible patients must have received prior therapy with either enzalutamide or abiraterone plus prednisone, and 1 line of prior taxane therapy or have refused or are ineligible for taxanes. Secondary endpoints include 5-year overall survival, tumor objective response rate, time to symptomatic skeletal event, progression free survival, and number of participants with treatment-related adverse events. Clinical trial information: NCT04876651.
Clinical • P3 data • Metastases
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FOLH1 expression • FOLH1 positive
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Xtandi (enzalutamide) • abiraterone acetate • 177Lu-rosopatamab tetraxetan (TLX591)
almost2years
Safety, tolerability, and dosimetry of 177Lu-TLX591 with best standard of care in patients with PSMA-expressing metastatic castration-resistant prostate cancer (ProstAct-SELECT). (ASCO-GU 2024)
The primary endpoints include the absorbed radiation dose of administered 177Lu-TLX591 to kidneys, liver, lungs, spleen, bone/red marrow, and salivary glands; tumour-to-healthy tissue ratios and residence times; and type, frequency, and severity of TEAEs. Clinical trial information: NCT04786847.
Clinical • Metastases
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FOLH1 expression
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177Lu-rosopatamab tetraxetan (TLX591)
over2years
Prognostic value of neutrophil-to-lymphocyte ratio in patients with metastatic castration-resistant prostate cancer receiving prostate-specific membrane antigen targeted radionuclide therapy. (PubMed, Prostate)
NLR provides prognostic information in the setting of patients with mCRPC receiving treatment with PSMA-TRT.
Retrospective data • Journal • Metastases
|
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 177Lu-rosopatamab tetraxetan (TLX591) • Ac-225 rosopatamab tetraxetan (CONV01-α)
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