NCT05557708|Not Yet RecruitingEarly Phase 1DMCFDA Drug
A Safety Study of 212Pb-Pentixather Radioligand Therapy
Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)
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Sponsor study identifier
Secondary identifiers
interventional
20
1 country
1
Study Start
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients who have been diagnosed with, and previously treated, for atypical carcinoid lesions of the lung.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 20, 2022
Actual (reported)September 28, 2022
Actual (reported)July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Determine the recommended phase 2 dose of 212-Lead Pentixather
The recommended phase 2 dose is based on the number of dose limiting toxicities observed post-treatment.
3 months
Determine the targeting of atypical pulmonary neuroendocrine tumor and/or neuroendocrine carcinoma lesions with 203-Lead Pentixather SPECT/CT
baseline
Determine tumor response
3 months
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.
Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.
Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
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.
Yusuf Menda, MD
University of Iowa
First Submitted
September 20, 2022
First Posted
September 28, 2022
Study Start
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2028
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 8, 2025
Record last verified: 2025-07
Data are obtained from protected health information. Only data from study participants who consented to data sharing will be shared. Data type: * patient demographics (age at consent, self-identified race ethnicity and gender, insurance status) * tumor response (RECIST measures, imaging DICOM) * adverse event logs indicating CTCAEv5 term and severity on a per-subject basis * dosimetric analysis of 203-Lead Pentixather scans * dose limiting toxicities: type and incidence * diagnostic analysis of 203-Lead Pentixather and FDG PET/CT (or CT) scans
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Source: ClinicalTrials.gov.
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