Clinical Trial · NCT07047118

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)

Overview

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.

Sponsor

Novartis

Phase

Phase 2

ClinicalTrials.gov

NCT07047118

Study contact

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682

Drug / Compound

AAA617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Participants must be \[68Ga\]Ga-PSMA-11 PET/CT scan positive and eligible as determined by the sponsor's central reader.
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.
Previous treatment with a maximum of 2 taxane regimens is allowed.
An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade ≤2.
Participants eligible for PARPi and/or immune checkpoint inhibitor (per local testing and according to investigator's judgement) are eligible to participate if they have previous exposure to this(these) therapy(ies). Key
Participant must have prior exposure to at least one second generation ARPI in the metastatic/advanced setting.
Adult male participants with histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.

Exclusion

Prior treatment with any RLT (approved or investigational) is not allowed
Prior treatment with a protein degrader compound that targets AR is not allowed Other protocol-defined inclusion/exclusion criteria may apply.