RecruitingLiver CancerHepatocellular CarcinomaMetastatic Liver Cancer
68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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: Melissa Lumish
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ Participants receiving any other investigational agents.
- ✕ 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.
- ✕ Prior treatment with Y90 radioembolization for hepatocellular carcinoma.
- ✕ Participants who have undergone major surgery within 3 months of screening and have not adequately recovered.
- ✕ Known additional malignancy that currently requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- ✕ Participants with untreated brain metastases and/or carcinomatous meningitis will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases and are not using steroids for at least 7 days prior to trial treatment.
- ✕ Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Where it's recruiting
Ohio
Cleveland
Source: ClinicalTrials.gov · NCT06852820 · last updated 2026-05-08