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177lu-psma-617

Generic: vipivotide tetraxetan·Brand: Pluvicto·Code: 177Lu-PSMA-617

177lu-psma-617: 17 clinical trials tracked.

177lu-psma-617 evidence translation

What we can confirm

17 tracked trials

No verified listed developer

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about 177lu-psma-617, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 1 study sponsors
Clinical Trials (17)showing 10 most recent

A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

NCT07145177·Phase 1
Recruiting

Primary endpoint: Percentage of participants with treatment emergent adverse events.

Interventionalopen30 targetStarted 2026-03Completion 2030-101 site · United StatesUniversity of California, San Francisco

LU-TARGET: A Phase 1 Study of Lutetium-177-PSMA-617 Adjuvant Radiotherapy for IDH Wild Type Gliomas Expressing PSMA Following Standard Treatment

NCT07223034·Phase 1
Recruiting

Primary endpoint: Descriptively report the toxicity

Interventionalopen20 targetStarted 2025-10Completion 2027-107 sites · United StatesMemorial Sloan Kettering Cancer Center

A Phase II, Open-label, Multi-Center, Randomized Study of Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT06894511·Phase 2·NVS
Active, not recruiting

Primary endpoint: Safety: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

InterventionalRandomizedopen7 targetStarted 2025-09Completion 2026-105 sites · United StatesNovartis Pharmaceuticals

177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia

NCT07025512·Phase 2
Withdrawn

Primary endpoint: Safety and adverse events (AEs).

Interventionalopen0 targetStarted 2025-08Completion 2026-05M.D. Anderson Cancer Center

LASER - a Phase 2 Trial of 177Lu-PSMA-617 as Systemic Therapy for Renal Cell Carcinoma

NCT06964958·Phase 2

Primary endpoint: Objective Response Rate (ORR)

Interventionalopen24 targetStarted 2025-07Completion 2028-122 sites · United StatesDana-Farber Cancer Institute

A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Lutetium (177Lu) Vipivotide Tetraxetan in Adult Male Patients With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT07047118·Phase 2·NVS
Active, not recruiting

Primary endpoint: Prostate Specific Antigen 50 (PSA50) Rate

InterventionalRandomizedopen138 enrolledStarted 2025-07Completion 2028-0544 sites · Australia, Austria, Canada, China…Novartis Pharmaceuticals

A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer

NCT06531499·Phase 1·NVS
Recruiting

Primary endpoint: Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs

Interventionalopen106 targetStarted 2024-11Completion 2028-1121 sites · Germany, Netherlands, Spain, Switzerland…Novartis Pharmaceuticals

LuCarbo - a Phase 1a/1b Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer

NCT06303713·Phase 1
Active, not recruiting

Primary endpoint: Maximum tolerated dose (MTD) or the Recommended Phase 2 dose (RP2D) of carboplatin administered in combination with 177Lu-PSMA-617

Interventionalopen37 targetStarted 2024-05Completion 2027-033 sites · United StatesDana-Farber Cancer Institute

An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Moderately and Severely Impaired and With Normal Renal Function.

NCT06004661·Phase 2·NVS
Active, not recruiting

Primary endpoint: Absorbed radiation dose in kidneys and selected organs

Interventionalopen23 enrolledStarted 2024-04Completion 2026-129 sites · France, Germany, Italy, Spain…Novartis Pharmaceuticals

An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)

NCT05939414·Phase 3·NVS
Recruiting

Primary endpoint: Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS)

InterventionalRandomizedopen450 targetStarted 2024-03Completion 2031-1050 sites · Argentina, Australia, Austria, Belgium…Novartis Pharmaceuticals