RecruitingPhase 1 / Phase 2

Lead-212 PSV359 Therapy for Patients With Solid Tumors

A Phase I/IIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients With Solid Tumors That Are Known to be Fibroblast Activation Protein (FAP)-Positive

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an imaging drug, lead-203 PSV359, and a radiation treatment, lead-212 PSV359. It is for adults with solid tumors that have a protein called FAP and have grown into nearby tissue or spread to other parts of the body.

Phase I/IIa image-guided, alpha-particle therapy study of \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359 in patients with solid tumors that are known to be Fibroblast Activation Protein (FAP)-positive.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • Lab tests show that your organs work well enough.
  • You can do all or most daily activities without help (ECOG score of 0 or 1).
  • You are expected to live more than 3 months.
  • Your cancer has gotten worse despite standard treatment, or no standard treatment exists.
  • A scan taken 1 hour after lead-203 PSV359 shows the drug in at least one known tumor.
  • Tissue or cell tests confirm a solid tumor cancer that has grown into nearby tissue or spread to other parts of the body.

Who can't join

  • You have a known allergy to the study drug or its ingredients, including a past severe allergic reaction.
  • You have another active cancer or known cancer spread to the brain.
  • You are pregnant or breastfeeding.
  • You have an active or uncontrolled infection needing ongoing antibiotics or antifungal drugs in the 3 days before joining.
  • You have a health or social issue that could make the study unsafe or hard to follow, including radiation safety rules, or you currently misuse alcohol or illegal drugs.
  • You had major surgery within 21 days before study treatment, or have not recovered enough and become stable after surgery.
  • You were diagnosed with a blood clot in a deep vein or lung within 4 weeks before joining.
  • You received a live or weakened-virus vaccine within 7 days before joining, or cancer treatment that travels through the body within 4 weeks before study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 \[212Pb\]Pb-PSV359; the subject must be sufficiently recovered and stable before treatment administration * Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to enrollment into the study * Current abuse of alcohol or illicit drugs * Treatment with any live/attenuated vaccine in the 7 days prior to enrollment * Previous treatment with any systemic anticancer therapy within 4 weeks prior to treatment on study

Study sites (16)

CA

FL

KS

KY

MN

MO

NE

NY

OH

PA

TX

WI