Carcinoid Tumor LungEarly Phase 1NCT05557708
A Safety Study of 212Pb-Pentixather Radioligand Therapy
A Early Phase 1 study testing 212-Lead Pentixather and 203-Lead Pentixather SPECT/CT in people with Carcinoid Tumor Lung and Neuroendocrine Tumor of the Lung, run by Yusuf Menda at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Tumor Lung, Neuroendocrine Tumor of the Lung, Carcinoma, Small-Cell Lung
- What is being tested?
- 212-Lead Pentixather and 203-Lead Pentixather SPECT/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 30 Jun 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Iowa Health Care
Iowa City, Iowa, 52242
Yusuf Menda, MD, 319-356-3214, yusuf-menda@uiowa.edu
Kristin West, RN, BSN, kristin-gaimari-varner@uiowa.edu
About this study
Official title: Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)
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.
Read the detailed description
This is a study to determine what dose is acceptably safe for further testing.
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
- Being tested
- 212-Lead Pentixather, 203-Lead Pentixather SPECT/CT
- Keywords
- radioligand therapy, pentixather, Lead 203, Lead 212, alpha therapy, dosimetry
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
212-Lead PentixatherDrug
Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 212-Lead Pentixather; Diagnostic Test: 203-Lead Pentixather SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Determine the targeting of atypical pulmonary neuroendocrine tumor and/or neuroendocrine carcinoma lesions with 203-Lead Pentixather SPECT/CT
The number of lesions identified with 203-Lead Pentixather SPECT/CT will compared to FDG PET/CT and diagnostic CT scans at baseline.
Measured: baseline
Determine tumor response
Tumor response will be assessed using the Response Evaluation Criteria in Solid Tumours (RECIST, v 1.1).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoid Tumor LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yusuf Menda
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Holden Comprehensive Cancer Center
- Responsible party
- Sponsor-investigator, Yusuf Menda, University of Iowa
- Investigators
- Yusuf Menda, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557708
- Sponsor's protocol ID
- SPORE Project 2
- Other IDs
- 1P50CA302572-01
- Status last verified
- Jul 2025
- First submitted
- 20 Sep 2022
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 28744319Buck 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.
PubMed 35674738Serfling 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.
PubMed 35312939
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)
- ClinicalTrials.gov ID
- NCT05557708
- Acronym / sponsor ID
- SPORE Project 2
- Keywords
- radioligand therapy, pentixather, Lead 203, Lead 212, alpha therapy, dosimetry
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yusuf MendaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Holden Comprehensive Cancer Center
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a study to determine what dose is acceptably safe for further testing.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 212-Lead Pentixather | Experimental | Drug: 212-Lead Pentixather, Diagnostic Test: 203-Lead Pentixather SPECT/CTSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 212-Lead PentixatherPentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand. | Drug | 212-Lead Pentixather |
| 203-Lead Pentixather SPECT/CTPentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning. | Diagnostic test | 212-Lead Pentixather |
Primary outcome
Determine the recommended phase 2 dose of 212-Lead Pentixather
Time frame: 3 months
The recommended phase 2 dose is based on the number of dose limiting toxicities observed post-treatment.
2 secondary outcomes
Determine the targeting of atypical pulmonary neuroendocrine tumor and/or neuroendocrine carcinoma lesions with 203-Lead Pentixather SPECT/CT
Time frame: baseline
Determine tumor response
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 28744319Schottelius 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.
- Background: PubMed 35674738Buck 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.
- Background: PubMed 35312939Serfling 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yusuf Menda, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 212-Lead Pentixather and 203-Lead Pentixather SPECT/CT in people with Carcinoid Tumor Lung and Neuroendocrine Tumor of the Lung, run by Yusuf Menda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusuf Menda, MD (319-356-3214, yusuf-menda@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the recommended phase 2 dose of 212-Lead Pentixather (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557708, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.