Lutetium Lu-177 vipivotide tetraxetan

Generic Name
Lutetium Lu-177 vipivotide tetraxetan
Brand Names
Pluvicto
Drug Type
Small Molecule
Chemical Formula
C49H68LuN9O16
CAS Number
1703749-62-5
Unique Ingredient Identifier
G6UF363ECX
Background

Lutetium Lu-177 vipivotide tetraxetan is a radioligand therapeutic agent. It consists of a radionuclide, lutetium Lu-177, linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer.
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Indication

Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.

Associated Conditions
Metastatic Castration-Resistant Prostate Cancer (mCRPC), Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Associated Therapies
-

177Lu-PSMA-617 Managed Access Program for mCRPC Patients

First Posted Date
2021-04-01
Last Posted Date
2023-01-13
Lead Sponsor
Advanced Accelerator Applications
Registration Number
NCT04825652

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-01-22
Last Posted Date
2024-12-20
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1148
Registration Number
NCT04720157
Locations
🇺🇸

Mayo Clinic - Arizona Mayo Clinic Hospital, Scottsdale, Arizona, United States

🇺🇸

University of California San Diego - Moores Cancer Center, La Jolla, California, United States

🇺🇸

VA Greater LA Healthcare System, Los Angeles, California, United States

and more 65 locations

177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

First Posted Date
2020-12-30
Last Posted Date
2024-08-27
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
469
Registration Number
NCT04689828
Locations
🇺🇸

Beth Israel Deaconess Med Ctr Dept. of BIDMC, Boston, Massachusetts, United States

🇺🇸

Uni of TX MD Anderson Cancer Cntr, Houston, Texas, United States

🇺🇸

Univ of Florida College of Medicine x, Gainesville, Florida, United States

and more 18 locations

177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-12-11
Last Posted Date
2024-08-29
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
200
Registration Number
NCT04663997
Locations
🇨🇦

Tom Baker Cancer Centre, Calgary, Alberta, Canada

🇨🇦

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

🇨🇦

University Health Network, Toronto, Ontario, Canada

and more 7 locations

Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-06-23
Last Posted Date
2024-10-30
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
58
Registration Number
NCT04443062
Locations
🇨🇾

German Oncology Center, Limassol, Cyprus

🇳🇱

Amsterdam UMC, Amsterdam, Netherlands

🇳🇱

University Medical Center Groningen, Groningen, Netherlands

and more 1 locations

Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-06-12
Last Posted Date
2024-11-08
Lead Sponsor
Peter MacCallum Cancer Centre, Australia
Target Recruit Count
20
Registration Number
NCT04430192
Locations
🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-04-13
Last Posted Date
2023-07-06
Lead Sponsor
Peter MacCallum Cancer Centre, Australia
Target Recruit Count
130
Registration Number
NCT04343885
Locations
🇦🇺

Liverpool Hospital, Liverpool, New South Wales, Australia

🇦🇺

St Vincent's Hospital Sydney, Sydney, New South Wales, Australia

🇦🇺

Royal North Shore, St Leonards, New South Wales, Australia

and more 9 locations

177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC

First Posted Date
2018-06-04
Last Posted Date
2021-08-24
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
6
Registration Number
NCT03545165
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

First Posted Date
2018-04-30
Last Posted Date
2024-07-18
Lead Sponsor
Endocyte
Target Recruit Count
831
Registration Number
NCT03511664
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

🇨🇦

Sunnybrook Research Institute, Odette Cancer Center, Toronto, Ontario, Canada

and more 85 locations

Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-02-03
Last Posted Date
2023-11-02
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
50
Registration Number
NCT03042468
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

🇺🇸

Tulane Cancer Center Clinic, New Orleans, Louisiana, United States

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