Recruiting

JSB462 and Lutetium (177Lu) Vipivotide Tetraxetan Combination Treatment for PSMA-positive mCRPC

Study Aim

This study is a phase 2 trial testing the combination of JSB462 and Lutetium (177Lu) Vipivotide Tetraxetan treatment for prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). The main goals are to assess the Prostate Specific Antigen 50 (PSA50) rate, monitor incidence of side effects, count participants requiring dose adjustments, and measure duration of exposure to study treatment.

What is being tested

JSB462

+ AAA617

Drug

Who is being recruted

Urogenital Diseases+8

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: July 2025

See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals

Study ContactNovartis PharmaceuticalsMore contacts

Last updated: February 10, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 3, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to test a new treatment combination for adult males with a specific type of advanced prostate cancer known as PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The study investigates the effects of using a drug called JSB462 (Luxdegalutamide) together with another treatment, Lutetium (177Lu) Vipivotide Tetraxetan. This research is important because the condition being studied is challenging to treat, and finding effective treatments could significantly improve outcomes for patients who have not responded to other therapies. Participants in this trial will first go through a screening process and then be randomly assigned to receive JSB462, which is taken orally every day. After 14 days, participants will also start receiving Lutetium (177Lu) Vipivotide Tetraxetan via an IV infusion every six weeks, up to six times. The study will monitor the effectiveness of this treatment combination by looking for changes in the cancer's progression and any side effects. After completing the treatment, participants will have follow-up visits to check their safety and ongoing health, with data collected to assess long-term effects and survival rates.

Official TitleA 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

Principal SponsorNovartis Pharmaceuticals

Study ContactNovartis PharmaceuticalsMore contacts

Last updated: February 10, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

130 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms, Castration-Resistant

Criteria

7 inclusion criteria required to participate

Adult male participants with histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.

An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade ≤2.

At least 1 bone or visceral metastatic lesion present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to initiation of study treatment.

Participants must be [68Ga]Ga-PSMA-11 PET/CT scan positive and eligible as determined by the sponsor's central reader.

Show More Criteria

2 exclusion criteria prevent from participating

Prior treatment with any RLT (approved or investigational) is not allowed

Prior treatment with a protein degrader compound that targets AR is not allowed

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

JSB462 100 mg QD + AAA617 7.4 GBq Q6W

Group II

Experimental

JSB462 300 mg QD + AAA617 7.4 GBq Q6W

Group III

Active Comparator

AAA617 7.4 GBq Q6W

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 46 locations

Recruiting

Cancer And Blood Spclsts of AZ

Casa Grande, United StatesOpen Cancer And Blood Spclsts of AZ in Google Maps

Recruiting

Providence Saint Johns Health Ctr

Santa Monica, United States

Recruiting

Rocky Mountain Cancer Centers

Denver, United States

Recruiting

Yale University School Of Medicine

New Haven, United States

Recruiting

46 Study Centers