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
- VA Greater Los Angeles Healthcare System · Los Angeles, CA 90073Janake Wijesuriya · Study contact · 310-977-5209 · Janake.Wijesuriya@va.govGholam R Berenji, MD · Principal investigatorMore trials in Los Angeles
- UCLA Department of Medicine - Hematology/Oncology · Los Angeles, CA 90095Lim Christopher · Study contact · 310-633-8400 ext. 16043 · christopherlim@mednet.ucla.eduLee S Rosen, MD · Principal investigatorMore trials in Los Angeles
FL
- University of Miami · Miami, FL 33125Sandel Cepero · Study contact · 305-243-6855 · s.cepero@miami.eduEmily Jonczak, MD · Principal investigatorMore trials in Miami
- Biogenix · Miami, FL 33165Jerry Joseph · Study contact · 1-786-719-1799 · jjoseph@cira-health.comJulio Cordero · Principal investigatorMore trials in Miami
KS
- University of Kansas · Kansas City, KS 66205KUCC Nurse Navigation · Study contact · (913) 945-7752 · CTNurseNav@kumc.eduRaed Al-Rajabi, M.D. · Study contactMore trials in Kansas City
KY
- University of Kentucky · Lexington, KY 40536Sarah Martin · Study contact · 859-323-6837 · SarahC.Martin@uky.eduDenise Fabian, MD · Principal investigatorMore trials in Lexington
MN
- Mayo Clinic in Rochester, Minnesota · Rochester, MN 55905Cancer Center Clinical Trials Referral Office · Study contact · (855) 776-0015 · MAYOCLINICCANCERSTUDIES@mayo.eduThorardur R Halfdanarson, M.D. · Study contactMore trials in Rochester
MO
- Saint Louis University · St Louis, MO 63110Anna Scannell · Study contact · anna.scannell@health.slu.eduMedhat Osman, MD · Principal investigatorMore trials in St Louis
NE
- Nebraska Cancer Specialists · Omaha, NE 68130Hanna Kurz · Study contact · (402) 691-6974 · hkurz@nebraskacancer.comSamuel Mehr, M.D. · Principal investigatorMore trials in Omaha
NY
- Memorial Sloan Kettering Cancer Center - Main Campus · New York, NY 10065Daisy Yascaribay · Study contact · 332-229-1096 · yascard@mskcc.orgLisa Bodei, MD, PhD · Principal investigatorMore trials in New York
OH
- Cleveland Clinic · Cleveland, OH 44195Cancer Answer Line · Study contact · 866-223-8100 · kolliar@ccf.orgElcin Zan, MD · Principal investigatorMore trials in Cleveland
- Ohio State University · Columbus, OH 43221Pierce Burris · Study contact · 1-614-685-0720 · pierce.burris@osumc.eduVineeth Sukrithan, MD · Principal investigatorMore trials in Columbus
PA
- University of Pittsburgh Medical Center · Pittsburgh, PA 15232Eunice Acampado · Study contact · 412-623-1322 · acampadoem@upmc.eduRavi Patel, MD, PhD · Principal investigatorMore trials in Pittsburgh
TX
- UT Southwestern University Hospital Radiology Clinic · Dallas, TX 75390Radiology Clinical Research Center · Study contact · 214-645-1568 · RCRO@UTSouthwestern.eduOrhan K Oz, MD, PhD · Principal investigatorMore trials in Dallas
- MD Anderson Cancer Center · Houston, TX 77030Brian Briones · Study contact · 832-266-3892 · bbbriones@mdanderson.orgYang Lu, MD, PhD · Principal investigatorMore trials in Houston
WI
- University of Wisconsin · Madison, WI 53792Cancer Connect · Study contact · (800) 622-8922 · clinicaltrials@cancer.wisc.eduGrace Blitzer, M.D. · Study contactMore trials in Madison