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177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors

Trial Status: In Review

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.

Inclusion Criteria

  • Primary ductal or lobular breast cancer, non-small cell lung cancer, or malignant melanoma
  • Type I or Type II LM with a "confirmed" or "probable" diagnosis according to EANO-ESMO guidelines 2017
  • 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
  • Written informed consent obtained in accordance with local regulations
  • Presence of an intracerebroventricular access device before first dosing

Exclusion Criteria

  • Obstructive or symptomatic communicating hydrocephalus
  • Progressive systemic (extra-leptomeningeal) disease
  • Uncontrolled life-threatening infection
  • Ventriculo-peritoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts
  • 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
  • Severe non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, or gastrointestinal system toxicity Grade 3 or above prior to enrolment
  • Grade 4 nervous system disorder. Hearing loss or stable neurological deficits due to brain tumor are allowed
  • Unacceptable coagulation function prior to first dosing defined as INR Grade 2 or above
  • 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
  • Smallest diameter of treated or untreated nodular or linear leptomeningeal metastasis >0.5 cm on MRI (Part 2 only)

Texas

Houston
M D Anderson Cancer Center
Status: APPROVED

Part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will

receive a dosimetry dose followed by maximum of five 5-week cycles of treatment doses of

intracerebroventricular 177Lu-DTPA-omburtamab.

Part 2 is a cohort-expansion phase in which patients will receive a treatment at the

recommended dose determined in Part 1, until confirmed LM progression, unacceptable toxicity,

or for maximum of 5 cycles, whichever comes first; however, the total number of cycles will

be determined based upon data from Part 1 (e.g., the dosimetry data) to minimize the risk of

radiation necrosis and decreased neurological function End of treatment will take place

within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up

period. The patients will be followed for up until one year after first dose (Part 1) and 2

years after first dose (Part 2).

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Y-mAbs Therapeutics

  • Primary ID 302
  • Secondary IDs NCI-2020-14225
  • Clinicaltrials.gov ID NCT04315246