A Phase 1/2 interventional study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Pancreatic Ductal Adenocarcinoma, Gastric Cancer and Esophageal Cancer, sponsored by Perspective Therapeutics. Recruiting at 16 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Perspective Therapeutics · Phase 1/2, Interventional, and Treatment
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Among 804 studies in Stomach Neoplasms with a site in United States — 157 open to participants now, 239 under way, 12 of them phase 3. Stomach Neoplasms · United States.
Among the 804 studies in Stomach Neoplasms with a site in United States, this one is the 209th largest by planned enrollment of the 686 interventional ones that give a count, is one of 47 that started in 2025, is one of 109 in phase 1/2, reaches primary completion later than 140 of the 238 other live ones, and was the 725th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →157 of the 804 studies in Stomach Neoplasms with a site in United States are open now. Recruiting first, the newest first:
University of Illinois Chicago · Sites in United States
Ages 18+
Pfizer · Sites in United States
Ages 18+
Sutro Biopharma, Inc. · Sites in United States
Ages 18+
MacroGenics · Sites in United States
Ages 18+
GE Healthcare · Sites in United States, Sweden
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
804 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 380 · Phase 2 338 · Phase 3 45 · Phase 4 10
First in 1992; this study’s year is marked. 47 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 112 is above the median of 66 across 2,500 interventional studies indexed under Stomach Neoplasms.
Median enrollment 53 across the 686 interventional studies, 207 across the 83 observational. Of the 512 that completed or were terminated, 196 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
381 of 804 have an industry lead sponsor. The 10 most frequent:
Perspective Therapeutics is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Perspective Therapeutics has 1 study filed under Stomach Neoplasms — fewer than ten, so there is no comparison to draw.
81 of the studies in Stomach Neoplasms with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532006Phase 3Shanghai Henlius BiotechA Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer | 2027-06-01 |
| NCT07217704Phase 3SOFIEUsing 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer. | 2027-08-30 |
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
| NCT05183126University of Michigan Rogel Cancer CenterPharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer | 2026-11 |
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
Add all 81 to your calendar (.ics) → With an account.
Among the 804 studies in Stomach Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
Drug: [203Pb]Pb-PSV359 · Drug: [212Pb]Pb-PSV359
* 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
Drug: [203Pb]Pb-PSV359 · Drug: [212Pb]Pb-PSV359
\[203Pb\]Pb-PSV359 is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
\[212Pb\]Pb-PSV359 is administered by intravenous infusion for treatment of FAP expressing cancers.
Determination of safety and tolerability of [203Pb]Pb-PSV359
Incidence and severity of treatment-related adverse events following a single administration of \[203Pb\]Pb-PSV359 is determined
Time frame: 30 days (±1day) post dose
Determination of safety and tolerability of [212Pb]Pb-PSV359
Incidence and severity of treatment-related adverse events following a single and each repeated administration of \[212Pb\]Pb-PSV359 is determined
Time frame: Up to 3 years
To determine the recommended phase 2 dose of [212Pb]Pb-PSV359
The recommended phase 2 dose as determined by cohort observations and review by the Safety Monitoring Committee
Time frame: Up to approximately 6 months
Determination of duration of response following treatment with [212Pb]Pb-PSV359
Median duration of response for subjects receiving at least 1 administration of \[212Pb\]Pb-PSV359 is assessed by RECIST V1.1 criteria
Time frame: Up to 3 years
Determination of progression free survival following treatment with [212Pb]Pb-PSV359
Progression free survival for subjects receiving at least 1 administration of \[212Pb\]Pb-PSV359 is assessed by RECIST V1.1 criteria
Time frame: Up to 3 years
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Blood radioactivity pharmacokinetic parameter such as area under the plasma concentration versus time curve (AUC) is determined.
Time frame: Up to approximately 3 yrs
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Blood radioactivity pharmacokinetic parameter such as peak plasm concentration (Cmax) is determined
Time frame: up to approximately 3 years
Determination of pharmacokinetic properties of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359
Blood radioactivity pharmacokinetic parameter such as the time (Tmax) to reach the maximum concentration (Cmax) is determined
Time frame: up to approximately 3 years
Estimation of biodistribution of 203Pb PSV 359 using SPECT/CT scans
Activity in tumor(s) and organs as percentage of injected dose is assessed
Time frame: Up to approximately 3 years
Started Apr 2025 (actual). Primary completion is estimated for Jan 2028, 33 months after the start.
Of 89 industry-sponsored phase 1/2 interventional studies under Stomach Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 109. This study's planned 33 months is below that.
Counting every sponsor, half of 156 studies reached it within 60 months; a quarter within 41 and three quarters within 109.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Lead PB-212
Perspective Therapeutics