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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Leptomeningeal Metastasis, Solid Tumor, Adult

In brief

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.

Key facts

Study ID

NCT04315246

Run by

Y-mAbs Therapeutics

People needed

0

Starts

2022-08-31

Expected to finish

2024-12-31

Last updated by the study team

2022-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.
• Smallest diameter of treated or untreated nodular or linear leptomeningeal metastasis >0.5 cm on MRI (Part 2 only)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• The University of Washington — Seattle, Washington, United States
• The Christie Hospital NHS Foundation Trust — Manchester, United Kingdom
• The Royal Marsden Hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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