TheranosticTrials.org

Clinical Trial · NCT06852820

68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)

Overview

The purpose of this study is to look at the effects (good and bad) of a drug called 177Lu-PSMA-617 (also known as the study drug) when given to participants who have prostate specific membrane antigen (PSMA) positive liver cancer.

Sponsor

Case Comprehensive Cancer Center

Phase

Phase 2

Contacts

Melissa Lumish, MD (CONTACT)

melissa.lumish@uhhospitals.org

216-844-3951

Melissa Lumish, MD (PRINCIPAL_INVESTIGATOR)

Amit Mahipal, MBBS (CONTACT)

amit.mahipal@uhhospitals.org

ClinicalTrials.gov

NCT06852820

Drug / Compound

PSMA-617

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

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • ECOG performance status 0 or 1.
  • Participants must have received one prior line of systemic therapy for the treatment of metastatic and/or unresectable HCC including anti-PD-L1 therapy. Participants will be enrolled at the time of progression on first-line therapy for metastatic and/or unresectable disease.
  • Participants must have normal organ and marrow function as defined below:Absolute Neutrophil Count ≥ 1,500/mcL. Hemoglobin \> 9 g/dL. Platelet count ≥ 75,000/mcL. Serum creatinine ≤ 1.5 x institutional upper limit of normal or CrCl ≥60 mL/min using the Cockroft-Gault formula for participants with creatinine levels \>1.5 ULN.Child-Pugh class A or B7.
  • * Participants must have histologically, cytologically or radiographically confirmed hepatocellular carcinoma by LI-RADS30 with metastatic and/or unresectable disease.
  • Age \>18 years. Because no dosing or adverse event data are currently available on the use of 177Lu-PSMA-617 (Lu-177 vipivotide tetraxetan) in participants \<18 years of age, children are excluded from this study.

Exclusion

  • Participants who have undergone major surgery within 3 months of screening and have not adequately recovered.
  • Subject has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).
  • Ongoing grade 3 or higher toxicity from prior anticancer systemic therapy.
  • * Participants receiving any other investigational agents.
  • Prior treatment with Y90 radioembolization for hepatocellular carcinoma.