68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)
United States10 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically, cytologically or radiographically confirmed hepatocellular carcinoma by LI-RADS30 with metastatic and/or unresectable disease.
* 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.
* 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.
* ECOG performance status 0 or 1.
* 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.
* At least one target lesion measurable by RECIST 1.1 criteria.
* PSMA-PET demonstrating PSMA PET positive lesion (higher uptake in the tumor compared with background liver uptake).
* Participants must have the ability to understand and the willingness to sign a written informed consent document.
* Participants of childbearing age are using an appropriate method of contraception.
Exclusion Criteria:
* Participants rece…
What they're measuring
1
Percentage of Participants with PSMA-Avid Lesions on PET Imaging (≥50%)
Timeframe: 12 weeks post intervention
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]