Lead-212 PSV359 for Cancer

Recruiting at 1 trial location

Overseen By ClinicalTrials at Perspectivetherapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Perspective Therapeutics

Must not be taking: Antifungals, Antibiotics, Vaccines, others

Disqualifiers: Secondary malignancy, Brain metastases, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359, in individuals with solid tumors positive for a protein called FAP, found in certain cancers. The trial aims to evaluate the effectiveness and safety of these treatments. Participants will first receive [203Pb]Pb-PSV359 for imaging, followed by [212Pb]Pb-PSV359, a targeted radiotherapy, for treatment. This study suits individuals with confirmed advanced or spreading solid tumors who have not responded to standard treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had any systemic anticancer therapy within 4 weeks before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that two treatments, \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359, are being tested for safety in patients with solid tumors that have a specific protein called FAP (Fibroblast Activation Protein). Currently, no human safety results are available for \[203Pb\]Pb-PSV359, so its safety for people remains unknown.

For \[212Pb\]Pb-PSV359, the study is in its early stages, focusing on finding a safe dose. This phase typically involves a small group of participants to identify any immediate side effects. The primary goal is to ensure the treatment's safety and determine the best dose for future studies.

Since these are early trials, detailed safety information is not yet available. However, the trials are designed to closely monitor participants for any side effects, prioritizing safety before advancing to larger studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 because these treatments offer a novel approach to targeting FAP-expressing cancers. Unlike traditional cancer therapies, these compounds use radioactive isotopes like Lead-203 and Lead-212 to specifically target and destroy cancer cells while sparing healthy tissue. This targeted approach not only promises to enhance treatment effectiveness but also reduces the side effects typically associated with conventional cancer treatments. Additionally, the imaging capability of [203Pb]Pb-PSV359 allows for precise tracking of the cancer's response to therapy, providing a significant advantage in monitoring and adjusting treatment as needed.

What evidence suggests that this trial's treatments could be effective for FAP-positive solid tumors?

In this trial, [203Pb]Pb-PSV359 helps doctors visualize tumors expressing the Fibroblast Activation Protein (FAP), aiding in cancer localization within the body. Participants will receive [203Pb]Pb-PSV359 for imaging purposes. Meanwhile, [212Pb]Pb-PSV359 is administered to other participants for treatment, delivering radiation directly to cancer cells by specifically attaching to FAP. Early studies suggest this targeted method might enhance treatment effectiveness by better reaching the tumors. Both treatments in this trial aim for precision, focusing only on cancer cells and sparing healthy ones, which is a promising approach in cancer therapy. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or metastatic solid tumors, such as cancers of the head and neck, colorectal, ovarian, gastric, esophageal, stomach or pancreas. Participants must have a life expectancy over 3 months, good organ function and an ECOG status of 0-1. They should have progressive disease despite standard treatments or no available standard treatment.

Inclusion Criteria

My cancer is confirmed to be advanced or has spread to other parts.

My organ functions are within normal ranges.

My doctor expects me to live more than 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of [212Pb]Pb-PSV359 to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Variable duration based on dose escalation

Multiple visits for dose administration and monitoring

Dose Expansion

Participants receive [212Pb]Pb-PSV359 at the RP2D to evaluate antitumor efficacy and safety

Up to 3 years

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• [203Pb]Pb-PSV359
• [212Pb]Pb-PSV359

Trial Overview The study tests two radiopharmaceuticals: [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 targeting Fibroblast Activation Protein in patients with solid tumors. It's a Phase I/IIa trial to assess safety and effectiveness. Patients' tumor uptake of the drugs is checked using SPECT/CT scans.

How Is the Trial Designed?

Group I: Dose Expansion Experimental Treatment 2 Interventions

* Enrolled subjects are administered \[203Pb\]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers. * Enrolled subjects are administered \[212Pb\]Pb-PSV359 (RP2D determined previously) for treatment of FAP-expressing cancers

Group II: Dose Escalation Experimental Treatment 2 Interventions

* Enrolled subjects are administered \[203Pb\]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers. * Approximately Four cohorts of \[212Pb\]Pb-PSV359 dose levels will be explored for determining Recommended Phase 2 Dose (RP2D). Study subjects will be assigned to cohorts sequentially.

Who Is Running the Clinical Trial?

Perspective Therapeutics

Lead Sponsor

Trials

6

Recruited

710+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06710756

Lead-212 PSV359 Therapy for Patients With Solid Tumors 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 ...

2. perspectivetherapeutics.com perspectivetherapeutics.com/pr/perspective-therapeutics-announces-first-patient-dosed-with-psv359-in-the-second-cohort-of-a-phase-12a-study-in-patients-with-fap-positive-solid-tumors

Press Release PSV359 was designed to target and deliver 212Pb to tumor sites expressing FAP-α, associated with multiple highly prevalent solid tumors, with ...

3. healthscout.app healthscout.app/trial_match/drug/1040/?back=/trial_match/drugs/

Drug: [203Pb]Pb-PSV359 - HealthScout HealthScout AI summary: This trial enrolls adults with advanced, FAP-positive solid tumors who have progressed on or lack standard therapy, ...

4. stocktitan.net stocktitan.net/news/CATX/perspective-therapeutics-announces-first-patient-dosed-with-psv359-3rgbwnvl5xmy.html

Perspective Therapeutics Begins Novel Cancer Trial with ... Their patient selection methodology using companion diagnostic imaging ([203Pb]PSV359) aligns with precision medicine trends in oncology drug ...

5. perspectivetherapeutics.com perspectivetherapeutics.com/pipeline/psv359

PSV359 Program PSV359 is a clinical-stage radiopharmaceutical therapy for diagnosing and treating Fibroblast Activation Protein-alpha (FAP) expressing solid tumors.