Dosimetry and Bio-distribution of 203Pb-RMX-VH-PIB in Newly Diagnosed or Recurrent Patients With Solid Tumors: A Phase I Exploratory Study
The goal of this Phase I clinical trial is to evaluate how the imaging drug 203Pb- RMX-VH-PIB distributes in the body and how much radiation different organs receive in patients with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are: How does 203Pb-RMX-VH-PIB spread in the body (biodistribution)? What is the radiation dose delivered to organs (dosimetry)? Participants will: Receive a single intravenous (IV) injection of 203Pb-RMX-VH-PIB. Undergo multiple single-photon emission computed tomography/computed tomography (SPECT/CT) imaging scans. Have blood, urine, vital signs, and electrocardiogram (ECG) monitored for safety. Be followed for any side effects for up to 30 days.
• Signed informed consent.
• Subjects aged ≥18 years.
• Karnofsky status ≥60.
• Negative urine pregnancy test in women of childbearing potential.
• Histologically confirmed and /or highly suspicious GBM (Adult type Astrocytoma grade IV both IDH-Mutant and IDH-Wild Type) including primary, recurrent or stable enhancing residual or primary, recurrent or stable enhancing residual PDAC.
• a. GBM group i. Contrast enhanced Brain MRI image with results compatible with GBM within the 2 weeks of dosing day.
• ii. Tumor size of ≥ 1.0 cm in any dimension by MRI. iii. No antiangiogenic therapy within 4 weeks of the day of dosing. iv. No chemotherapy within 2 weeks of the day of dosing. v. Subjects receiving corticosteroids must be on a stable or decreasing dose regimen prior to enrollment b. PDAC group i. No chemotherapy within 2 weeks of the day of dosing ii. Tumor size of ≥ 1.0 cm in any dimension by MRI or CT
• Recent blood test results (within 4 weeks pre-dose) as follows:
‣ WBC: ≥ 2 x 109/L
⁃ Haemoglobin: ≥ 8 g/dL
⁃ Platelets: ≥75 x 109/L
⁃ ALT, AST, AP ≤ 5 times ULN
⁃ Bilirubin: ≤ 2 times ULN
⁃ Creatinine clearance ≥ 60 mL/min, calculated by the Cockcroft-Gault equation