XCancer

Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Glioblastoma Multiform (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC)

Description:

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.

Sponsor:

RadioMedix

Phase:

Phase 1

Contacts:

Ebrahim Delpassand, MD, FACNM (STUDY_CHAIR)

Ebrahim Delpassand, MD, FACNM (CONTACT)

edelpassand@radiomedix.com

713-499-9733

Izabela Tworowska, MSPharm, PhD (CONTACT)

itworowska@radiomedix.com

832-868-2812

Government Study Link:

NCT07733674 - Click here to see study on

ClinicalTrials.gov

RMX-VH-PIB

Isotope(s):
Target(s):
  • No Explicit Target
Ligand Class: Peptides
Inclusion
  • Creatinine clearance ≥ 60 mL/min, calculated by the Cockcroft-Gault equation
  • Haemoglobin: ≥ 8 g/dL
  • 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
Exclusion
  • Participants who are currently receiving treatment with statins (HMG-CoA reductase inhibitors), including but not limited to atorvastatin, rosuvastatin, pitavastatin, simvastatin, lovastatin, pravastatin, or fluvastatin, are excluded unless the medication has been discontinued for at least four (4) drug half-lives prior to administration of the investigational product
  • In GBM groups participants requiring MRI: History of hypersensitivity or contraindication to gadolinium-based contrast agents, including prior allergic or anaphylactoid reactions to gadolinium contrast media, or any condition (e.g., severe renal impairment, acute kidney injury) that, in the investigator's judgment, increases the risk associated with gadolinium administration.
  • In PDAC groups participants requiring CT scans: Any contraindications to iodinated contrast agents include a history of severe hypersensitivity or allergic reaction to iodinated contrast media, significant renal impairment (e.g., eGFR \< 30 mL/min/1.73 m² or acute kidney injury), uncontrolled hyperthyroidism or other thyroid disorders that may worsen with iodine exposure, prior contrast-induced nephropathy, pregnancy, and any unstable medical condition such as severe heart failure or hemodynamic instability that, in the investigator's judgment, increases the risk of contrast administration.