RecruitingPhase 2NCT07047118

A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

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)

Sponsor

Novartis Pharmaceuticals

Enrollment

130 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

Prostatic Cancer, Castration-Resistant

Summary

This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Resistant Prostate Cancer (mCRPC) with prior exposure to at least 1 Androgen Receptor Pathway Inhibitor (ARPI) and 0-2 taxane regimens and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and pharmacokinetic (PK) data from participants randomized in the study will be evaluated.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments for advanced prostate cancer that has stopped responding to standard hormone therapy (called metastatic castration-resistant prostate cancer, or mCRPC): JSB462 (a next-generation hormone-blocking drug called luxdegalutamide) plus a radioactive therapy called lutetium-177 PSMA (177Lu-PSMA), which delivers radiation directly to cancer cells via a targeting molecule. **You may be eligible if...** - You are an adult male with confirmed prostate cancer (adenocarcinoma) - Your cancer has spread to bones or other organs and has stopped responding to hormone therapy - Your PSMA PET scan is positive (the cancer has the PSMA target) - You have received at least one prior second-generation hormone-blocking drug - Your general health score (ECOG) is 2 or lower **You may NOT be eligible if...** - You have mixed neuroendocrine prostate cancer - You have received any prior radioligand therapy (like lutetium-177 PSMA) - You have received a prior AR-targeted protein degrader drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJSB462

Administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision

DRUGAAA617

administered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision

Locations(50)

Cancer And Blood Spclsts of AZ

Casa Grande, Arizona, United States

Highlands Oncology Group

Fayetteville, Arkansas, United States

City of Hope National Medical

Duarte, California, United States

Providence Saint Johns Health Ctr

Santa Monica, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Indiana University

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

XCancer Omaha LLC

Omaha, Nebraska, United States

NYU Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Univ of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Texas Oncology Sammons Cancer Center

Dallas, Texas, United States

Urology San Antonio

San Antonio, Texas, United States

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Novartis Investigative Site

Adelaide, South Australia, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Innsbruck, Tyrol, Austria

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Burnaby, British Columbia, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Olomouc, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Brest, France

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Tours, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Afula, Israel

Novartis Investigative Site

Beersheba, Israel

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Nijmegen, Gerlderland, Netherlands

Novartis Investigative Site

Leeuwarden, Provincie Friesland, Netherlands

Novartis Investigative Site

Hoofddorp, Netherlands

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Granada, Andalusia, Spain

Novartis Investigative Site

El Palmar, Murcia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Seville, Spain

Novartis Investigative Site

Taipei, Taiwan

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NCT07047118

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