68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMelissa Lumish
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Lu-PSMA-617
DrugGiven IV
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Lu-PSMA-617Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants with PSMA-Avid Lesions on PET Imaging (≥50%)
Study is feasible if at least 1 PSMA-PET positive lesion is identified in at least 50% of the participants in this cohort
Time frame
12 weeks post intervention2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame
240 days post treatmentSecondary outcomes
1
Progression free survival (PFS)
PFS will be estimated using Kaplan-Meier method
Time frame
24 weeks post intervention2
Median overall survival(OS)
OS will be estimated using Kaplan-Meier method
Time frame
52 weeks post intervention3
Objective response rate(ORR)
The ORR will be estimated based on the number of participants with clinical response using a binomial distribution and its confidence interval will be estimated using Wilson's method
Time frame
12 weeks post intervention4
Clinical benefit rate
Clinical benefit rate as defined as proportion of participants with objective responses or stable disease at 12 weeks
Time frame
12 weeks post interventionSponsors and contacts
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Source ClinicalTrials.gov