Therapy Detail

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Therapy Name lutetium Lu 177 vipivotide tetraxetan
Synonyms
Therapy Description

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioconjugate comprising a prostate-specific membrane antigen (PSMA) inhibitor radiolabeled with Lu177, which targets PSMA expressing cells, potentially resulting in decreased tumor growth (PMID: 25883127, PMID: 26795286, PMID: 32760622). Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is FDA approved for use in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor (AR) pathway inhibition and taxane-based chemotherapy (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
lutetium Lu 177 vipivotide tetraxetan Pluvicto Lu177-PSMA-617|Vipivotide tetraxetan Lu-177 Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioconjugate comprising a prostate-specific membrane antigen (PSMA) inhibitor radiolabeled with Lu177, which targets PSMA expressing cells, potentially resulting in decreased tumor growth (PMID: 25883127, PMID: 26795286, PMID: 32760622). Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is FDA approved for use in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have received androgen receptor (AR) pathway inhibition and taxane-based chemotherapy (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05204927 Phase III Abiraterone + Enzalutamide lutetium Lu 177 vipivotide tetraxetan Abiraterone + Prednisone Lu-177-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer Active, not recruiting USA | ITA | FRA | ESP 0
NCT06084338 Phase II lutetium Lu 177 vipivotide tetraxetan + Testosterone lutetium Lu 177 vipivotide tetraxetan Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc Recruiting USA 0
NCT06145633 Phase II lutetium Lu 177 vipivotide tetraxetan Vorinostat Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer Not yet recruiting USA 0
NCT04430192 Phase Ib/II lutetium Lu 177 vipivotide tetraxetan Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy (LuTectomy) Active, not recruiting AUS 0
NCT05849298 Phase II lutetium Lu 177 vipivotide tetraxetan Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + lutetium Lu 177 vipivotide tetraxetan Apalutamide + lutetium Lu 177 vipivotide tetraxetan A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC (PSMACare) Recruiting USA | ESP | CAN 4
NCT06388369 Phase Ib/II lutetium Lu 177 vipivotide tetraxetan Ipilimumab + lutetium Lu 177 vipivotide tetraxetan Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer (NEPI) Not yet recruiting DEU 0
NCT04720157 Phase III lutetium Lu 177 vipivotide tetraxetan 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 (PSMAddition) Active, not recruiting USA | NLD | GBR | FRA | ESP | DEU | CAN | BEL | AUT 10
NCT03511664 Phase III lutetium Lu 177 vipivotide tetraxetan Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION) Completed USA | NLD | GBR | FRA | DEU | CAN | BEL 3
NCT05682443 Phase II lutetium Lu 177 vipivotide tetraxetan + ONC-392 lutetium Lu 177 vipivotide tetraxetan ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC (PRESERVE-006) Recruiting USA 0
NCT05150236 Phase II Ipilimumab + lutetium Lu 177 vipivotide tetraxetan + Nivolumab lutetium Lu 177 vipivotide tetraxetan Nivolumab 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC (EVOLUTION) (EVOLUTION) Active, not recruiting AUS 0
NCT04443062 Phase II lutetium Lu 177 vipivotide tetraxetan Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer (Bullseye) Recruiting NLD 1
NCT03042468 Phase I lutetium Lu 177 vipivotide tetraxetan Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC Active, not recruiting USA 0
NCT04663997 Phase II Docetaxel lutetium Lu 177 vipivotide tetraxetan 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer Active, not recruiting CAN 0
NCT05079698 Phase I lutetium Lu 177 vipivotide tetraxetan A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer Active, not recruiting USA 0
NCT04689828 Phase III lutetium Lu 177 vipivotide tetraxetan 177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer Active, not recruiting USA | NLD | GBR | FRA | ESP | DEU | CAN | BEL | AUT 5
NCT06200103 FDA approved lutetium Lu 177 vipivotide tetraxetan Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer Recruiting USA 0
NCT06288113 Phase II lutetium Lu 177 vipivotide tetraxetan Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial Not yet recruiting USA 0
NCT06216249 Phase II lutetium Lu 177 vipivotide tetraxetan Evaluation of a Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer Not yet recruiting USA 0


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