TheranosticTrials.org

Clinical Trial · NCT04315246

177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma)

Overview

Adults with leptomeningeal metastasis from solid tumors will be treated with 177Lu-DTPA-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting B7-H3.

Sponsor

Y-mAbs Therapeutics, Inc.

Phase

Phase 1/2

ClinicalTrials.gov

NCT04315246

Drug / Compound

DTPA-omburtamab

Isotope(s):
Target(s):
  • B7H3
Ligand Class: Antibodies
Chelator: DTPA

Eligibility

Inclusion

  • Type I or Type II LM with a "confirmed" or "probable" diagnosis according to EANO-ESMO guidelines 2017
  • Presence of an intracerebroventricular access device before first dosing
  • Life expectancy more than 2 months, as judged by the Investigator
  • ECOG Performance status 0, 1, or 2
  • Acceptable hematological status and liver and kidney function

Exclusion

  • Uncontrolled life-threatening infection
  • Severe non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, or gastrointestinal system toxicity Grade 3 or above prior to enrolment
  • Received craniospinal irradiation (for intraparenchymal or dural metastases) or intrathecal cytotoxic anti-cancer therapy less than 3 weeks prior to first dose of 177Lu-DTPA-omburtamab
  • Progressive systemic (extra-leptomeningeal) disease
  • Smallest diameter of treated or untreated nodular or linear leptomeningeal metastasis \>0.5 cm on MRI (Part 2 only)
  • Unacceptable coagulation function prior to first dosing defined as INR Grade 2 or above
  • Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.
  • Female of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods or male who is not using highly effective contraceptive method
  • Obstructive or symptomatic communicating hydrocephalus
  • Ventriculo-peritoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts