XCancer

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

Description:

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)

Government Study Link:

NCT05682443 - Click here to see study on

ClinicalTrials.gov

PSMA-617

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