Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05557708 | Not yet recruiting | Carcinoid Tumor Lung

A Safety Study of 212Pb-Pentixather Radioligand Therapy
Sponsor:

Yusuf Menda

Information provided by (Responsible Party):

Yusuf Menda

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.

Condition or disease

Carcinoid Tumor Lung

Neuroendocrine Tumor of the Lung

Carcinoma, Small-Cell Lung

Intervention/treatment

212-Lead Pentixather

203-Lead Pentixather SPECT/CT

Phase

Early Phase 1

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 Type : Interventional
Estimated Enrollment : 20 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Phase 1 Trial of Dosimetry Guided 212Pb-pentixather Radioligand Therapy in Patients With Atypical Lung Carcinoids and Neuroendocrine Carcinomas
Actual Study Start Date : July 1, 2024
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2028
Arm Intervention/treatment

Experimental: 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.

Drug: 212-Lead Pentixather

Diagnostic Test: 203-Lead Pentixather SPECT/CT
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
A Safety Study of 212Pb-Pentixather Radioligand Therapy

Location Details

Please Choose a site

A Safety Study of 212Pb-Pentixather Radioligand Therapy

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Iowa

The University of Iowa Theranostics Center

Iowa City, Iowa, United States, 52242