Liver Cancer study: Lu-PSMA-617
Official title 68Ga-PSMA-11 PET-directed Radioligand Therapy in Metastatic Hepatocellular Carcinoma (HCC)
ClinicalTrials.gov ID: NCT06852820
What this study is testing
What is Lu-PSMA-617?
An investigational intravenous drug being studied for liver cancer that expresses PSMA. It is designed to deliver targeted radiation to PSMA‑positive tumor blood vessels.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how the drug works and what side‑effects it may cause in these patients.
- Who it's for
- It is looking for adults who have liver cancer that spreads and whose tumors show PSMA on imaging.
- What's involved
- Participants will receive the drug and have regular visits and scans to monitor the cancer and any side‑effects.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically, cytologically or radiographically confirmed hepatocellular carcinoma by LI-RADS30 with metastatic and/or...
- Participants must have received one prior line of systemic therapy for the treatment of metastatic and/or unresectable HCC including anti-PD-L1...
- 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...
- 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.
You likely can't join 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.
See the full eligibility 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.
- 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.
- 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.
- 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...
- 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...
- 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...
- Participants with known psychiatric or substance use disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator.
- Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 7 months for females and 14 weeks for males after...
- Subject has received live vaccine within 30 days prior to the first dose of trial treatment.
- Subject with recent variceal bleeding, gastrointestinal bleeding or high risk of bleeding.
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.