Study Title

novartis

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)

Study Details

Description:

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
Contacts:

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111

Novartis Pharmaceuticals

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

Drug Details

AAA617

Isotope(s):
Target(s):
  • PSMA
Ligand: Small Molecules
Chelator: DOTA

Inclusion

Inclusion Criteria Not Yet Provided

Exclusion

Exclusion Criteria Not Yet Provided

Patient Education

Patient Education Not Yet Provided

Publications

Publications Not Yet Provided

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