Lead-212 PSV359 for Cancer

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

Trial Summary

What is the purpose of this trial?

Phase I/IIa clinical study evaluating the safety and efficacy of peptide-based theranostic (therapeutic and diagnostic) radiopharmaceuticals, i.e. \[203Pb\]Pb-PSV359 and \[212Pb\]Pb-PSV359 targeting Fibroblast Activation Protein in subjects with solid tumors.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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. * Enrolled subjects are administered \[212Pb\]Pb-PSV359 (starting at 2.5 mCi upto 10 mCi) for treatment of FAP-expressing cancers and for determining Recommended Phase 2 Dose (RP2D)

Who Is Running the Clinical Trial?

Perspective Therapeutics

Lead Sponsor

Trials

6

Recruited

710+