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

ID#: NCT04315246

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: September 30, 2021

End Date: December 31, 2024

Contact Information:
Joris Wilms
Summary: 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)