Clinical Trial · NCT05682443

ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

Overview

In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.

Sponsor

OncoC4, Inc

Phase

Phase 1/2

Contacts

David Wise, MD (PRINCIPAL_INVESTIGATOR)

Mark Stein, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05682443

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Patients must have a life expectancy \> 6 months.
Patients must have histological or cytological confirmation of prostate adenocarcinoma.
1. Patients must be ≥ 18 years of age and have the ability to understand and sign an approved informed consent form (ICF).
Patients must have a positive PSMA in an FDA-approved PSMA PET scan. A positive PSMA is defined as at least one tumor lesion with PSMA uptake greater than normal liver.
Patients must have an ECOG performance status of 0 or 1.

Exclusion

Transfusion within 14 days of first day of study treatment
Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
Known hypersensitivity to the components of the study therapy or its analogs.
1. Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to prior cancer therapeutics except neuropathy or endocrinopathy with Gr 2 or less.
Any systemic anti-cancer therapy within 5 half-lives or 14 days, whichever is shorter (small molecule drugs) or within 28 days for antibody based therapy, prior to starting study treatment.