Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether [212Pb]Pb-PSV359 can bind fibroblast activation protein (FAP) on cancer-associated fibroblasts—support cells around some tumours—and deliver targeted alpha-particle radiation to the tumour environment. The related [203Pb]Pb-PSV359 scan will show where the drug travels and how much reaches tumours and organs.
The idea is that directing radiation through FAP-positive tumour tissue could deliver it more locally than an untargeted treatment, but this trial mainly measures safety, tolerability and the dose that can be given, not whether patients live longer or go longer before the cancer grows.
Worth knowing: This is an open-label, non-randomised dose-finding and expansion study with no comparison group, and eligibility requires a positive FAP imaging scan rather than a particular tumour genotype.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06710756 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 112 people (planned) |
| Who can join | aged 18 Years to 90 Years |
| Run by | Perspective Therapeutics |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug [203Pb]Pb-PSV359
- Drug [212Pb]Pb-PSV359
What it is measuring
Determination of safety and tolerability of [203Pb]Pb-PSV359
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a prospective, multi-center open label dose finding, dose expansion study of [212Pb]Pb-PSV359 in subjects with a positive Fibroblast Activation Protein (FAP) imaging scan with imaging agent.
FAP is specifically expressed on the surface of cancer-associated fibroblasts in some tumor tissues and therefore is an attractive target in the diagnosis and treatment of various cancers. Lead-212 ([212Pb]Pb-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that have potential to improve delivery of a highly effective form of radiation.
This study will be conducted in 2 parts:
Part 1: Dose-escalation: [212Pb]Pb-PSV359 is administered in escalating doses to determine the Maximum Tolerated radioactivity (MTD) Dose and potential recommended Phase 2 dose (RP2D).
Part 2: Dose-expansion: This part will enroll subjects in expansion cohorts based on the identified MTD and RP2D for the selection of [212Pb]Pb-PSV359 doses for further clinical development.
A Dosimetry sub-set utilizing an imaging surrogate, [203Pb]Pb-PSV359, has been incorporated into the study in order to assess organ biodistribution and tumor uptake of the investigational products. This sub study will also estimate radiation dosimetry and correlate uptake of the investigation products with observed toxicities and efficacy.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Aged ≥ 18 years
- Satisfactory organ function as determined by laboratory testing
- Eastern Cooperative Oncology Group performance (ECOG) status of 0 to 1
- Life expectancy > 3 months
- Progressive disease despite standard therapy or for whom no standard therapy exists
- Positive [203Pb]Pb-PSV359 SPECT/CT scan showing uptake of [203Pb]Pb-PSV359 in at least 1 known lesion on the 1-hour SPECT/ CT scan
- Histological, pathological, and/or cytological confirmation of solid tumor malignancy that is locally advanced or metastatic
Exclusion Criteria
- Known hypersensitivity to the active agent or any of the excipients
- Active secondary malignancy
- Pregnancy or breastfeeding a child
- Known brain metastases
- Known active or uncontrolled infections requiring ongoing antifungals or antibiotics in the 3 days prior to enrollment
- Known medical condition which would make this protocol unreasonably hazardous for the patient
- Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions
- Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the investigational product or excipients
- Major surgery within 21 days prior to the administration of [212P…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 11 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06710756, registered by Perspective Therapeutics on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.