Status:
WITHDRAWN
177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma)
Lead Sponsor:
Y-mAbs Therapeutics
Conditions:
Leptomeningeal Metastasis
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
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 intracerebroventric...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04315246
Start Date
August 31 2022
End Date
December 31 2024
Last Update
July 15 2022
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Johns Hopkins
Baltimore, Maryland, United States, 21287
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Duke Cancer Center
Durham, North Carolina, United States, 27710