177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma)
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Key facts
- Where
- Baltimore, Durham, Houston, Los Angeles, New York és Seattle, Egyesült ÁllamokSee the 6 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- Johns HopkinsBaltimore, Egyesült ÁllamokNo longer taking part
- Duke Cancer CenterDurham, Egyesült ÁllamokNo longer taking part
- M D Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
- The University of WashingtonSeattle, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Y-mAbs Therapeutics
- Trial code
- NCT04315246
- Record updated
- 2022. július 15.
- Original description
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.Read full original descriptionShow less
A Phase I/II Trial of Intracerebroventricular 177Lu DTPA Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors
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: 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: 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; Progressive systemic (extra-leptomeningeal) disease; Uncontrolled life-threatening infection; Grade 4 nervous system disorder. Hearing loss or stable neurological deficits due to brain tumor are allowed; Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial; Unacceptable coagulation function prior to first dosing defined as INR Grade 2 or above; Obstructive or symptomatic communicating hydrocephalus; Ventriculo-peritoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts; 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).