TheranosticTrials.org

Clinical Trial · NCT07661420

211At-MABG in Adults With Advanced Neuroendocrine Cancers

Overview

Phase I dose escalation study of 211At-MABG in adults with advanced pheochromocytoma / paraganglioma (PPGL) or other NET-overexpressing cancers (as evidenced by positive MIBG imaging) who are refractory to, lacking, or ineligible for approved treatments. Phase 1 dose-escalation will follow a standard 3+3 design with an expansion cohort at the recommended phase two dose (RP2D).

Sponsor

University of Pennsylvania

Phase

Phase 1

Contacts

Abramson Cancer Center (CONTACT)

Vivek Narayan, MD, MS (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07661420

Drug / Compound

MABG

Isotope(s):
Target(s):
  • NET
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Hemoglobin ≥ 9 g/dL
  • Advanced neuroendocrine cancers requiring systemic therapy and refractory to, ineligible for, declining, or lacking standard treatments.
  • Serum bilirubin ≤ 1.5x upper limit of normal
  • Measured or estimated GFR ≥ 60 mL/min
  • I MIBG imaging indicating MIBG-avid disease (radiotracer uptake above background in at least one tumor site) per Investigator/Sub-Investigator assessment.
  • Absolute neutrophil count ≥ 1,500/mm³
  • ECOG performance status ≤ 2.
  • Platelet count ≥ 75,000/mm³
  • ALT/AST each ≤ 2.5x upper limit of normal

Exclusion

  • Uncontrolled brain metastasis (Participant must be at least 4 weeks since CNS-directed therapy and no longer requiring corticosteroid therapy).
  • Anticancer therapy, except hormonal therapy or bone supportive therapies, within 14 days of cycle 1 day 1.