A Safety Study of 212Pb-Pentixather Radioligand Therapy

Yusuf Menda

Status and phase: Begins enrollment in 4 months; Early Phase 1

Conditions: Neuroendocrine Tumor of the Lung; Carcinoma, Small-Cell Lung; Carcinoid Tumor Lung

Treatments: Diagnostic Test: 203-Lead Pentixather SPECT/CT; Drug: 212-Lead Pentixather

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05557708

1P50CA302572-01 (Other Identifier)

SPORE Project 2

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

212-Lead Pentixather

Experimental group

Description:

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.

Treatment:

Drug: 212-Lead Pentixather

Diagnostic Test: 203-Lead Pentixather SPECT/CT