A Safety Study of 212Pb-Pentixather Radioligand Therapy
NCT ID: NCT05557708
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2026-07-01
2030-06-30
Brief Summary
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Detailed Description
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In this study, participants are asked to:
* undergo SPECT/CT imaging with Lead-203 Pentixather (a radiotracer) to ensure the tumor lesions have the needed receptors
* undergo serial blood sampling for during and after the SPECT/CT scan for radiation and dosimetry calculations (to determine how much of the Lead-212 Pentixather to administer)
* receive up to 2 infusions of arginine \& lysine as a kidney protectant
* receive up to 2 infusions of Lead-212 Pentixather, 6 weeks between each infusion
* undergo imaging at 3 months post treatment to determine disease response
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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212-Lead Pentixather
Single intravenous infusion of Pentixather radiolabeled with Lead-212. Administered activity to participant is calculated from bone marrow and renal radiation constraints.
Treatment is administered in 2 cycles with 6 weeks between the cycles.
212-Lead Pentixather
Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.
203-Lead Pentixather SPECT/CT
Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.
Interventions
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212-Lead Pentixather
Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.
203-Lead Pentixather SPECT/CT
Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.
Eligibility Criteria
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Inclusion Criteria
* adequate bone marrow function (platelet count ≥ 100,000; hemoglobin of ≥ 10 g/dL; neutrophil count ≥ 1,500 cells/mm3)
* adequate kidney function (creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault equation
* adequate liver function (serum bilirubin ≤ 3x the upper limit of normal, AST ≤ 5x the upper limit of normal, and ALT ≤ 5x the upper limit of normal)
* failed initial therapy or declined further therapy known to confer benefit
* have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pentixather SPECT/CT
Exclusion Criteria
* antoher investigational agent within 4 weeks of consent
* uncontrolled illness including, but not limited to, ongoing or active infection that would necessitate a delay in therapy or cause a hospital admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic cirrhosis or severe impairment, or psychiatric illness/social situations that would limit compliance with study requirements.
* prior solid organ transplant
* cytotoxic or antineoplastic therapy within 21 days of consent (42 days for nitrosoureas)
* antibody therapy within the 21 days of consent
* allogenic bone marrow or stem cell transplant, or any stem cell infusion, within 84 days of consent
* pregnancy
* breastfeeding
* refusal to comply with birth control requirements during study
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Holden Comprehensive Cancer Center
OTHER
Yusuf Menda
OTHER
Responsible Party
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Yusuf Menda
Professor and Director, Nuclear Medicine
Principal Investigators
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Yusuf Menda, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Health Care
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Schottelius M, Osl T, Poschenrieder A, Hoffmann F, Beykan S, Hanscheid H, Schirbel A, Buck AK, Kropf S, Schwaiger M, Keller U, Lassmann M, Wester HJ. [177Lu]pentixather: Comprehensive Preclinical Characterization of a First CXCR4-directed Endoradiotherapeutic Agent. Theranostics. 2017 Jun 11;7(9):2350-2362. doi: 10.7150/thno.19119. eCollection 2017.
Buck AK, Serfling SE, Lindner T, Hanscheid H, Schirbel A, Hahner S, Fassnacht M, Einsele H, Werner RA. CXCR4-targeted theranostics in oncology. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4133-4144. doi: 10.1007/s00259-022-05849-y. Epub 2022 Jun 8.
Serfling SE, Lapa C, Dreher N, Hartrampf PE, Rowe SP, Higuchi T, Schirbel A, Weich A, Hahner S, Fassnacht M, Buck AK, Werner RA. Impact of Tumor Burden on Normal Organ Distribution in Patients Imaged with CXCR4-Targeted [68Ga]Ga-PentixaFor PET/CT. Mol Imaging Biol. 2022 Aug;24(4):659-665. doi: 10.1007/s11307-022-01717-1. Epub 2022 Mar 21.
Other Identifiers
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SPORE Project 2
Identifier Type: -
Identifier Source: org_study_id
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