NCT05557708

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
49mo left

Started Jul 2026

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
3.8 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

September 20, 2022

Last Update Submit

July 2, 2025

Conditions

Carcinoid Tumor LungNeuroendocrine Tumor of the LungCarcinoma, Small-Cell Lung

Keywords

radioligand therapypentixatherLead 203Lead 212alpha therapydosimetry

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (1)

212-Lead Pentixather

EXPERIMENTAL

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.

Drug: 212-Lead PentixatherDiagnostic Test: 203-Lead Pentixather SPECT/CT

Interventions

212-Lead PentixatherDRUG

Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.

212-Lead Pentixather
203-Lead Pentixather SPECT/CTDIAGNOSTIC_TEST

Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.

212-Lead Pentixather

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ability to provide independent consent
  • 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

You may not qualify if:

  • major surgery within 4 weeks of consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

  • 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.

    PMID: 28744319BACKGROUND

  • 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.

    PMID: 35674738BACKGROUND

  • 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.

    PMID: 35312939BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yusuf Menda, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yusuf Menda, MD

CONTACT

319-356-3214yusuf-menda@uiowa.edu

Kellie Bodeker, Ph.D.

CONTACT

319-384-9425kellie-bodeker@uiowa.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Director, Nuclear Medicine

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 28, 2022

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2030

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Protocol and ICF are made available upon request by email. All documents (Protocol, ICF, SAP, CSR, and analytic code) will be made available after primary objective is completed.
Access Criteria
A materials transfer agreement or data usage agreement (depending upon the legal department's preference) will need to be fully executed prior to sharing.

Locations

US(1)