Clinical trial · Interventional
177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma)
A Phase I/II Trial of Intracerebroventricular 177Lu DTPA Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors
NCT04315246CI-TRIAL-00059670withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business priorities
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Metastasis | Meningeal Carcinomatosis | PROBABILISTIC | 0.70 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiolabeled DPTA-omburtamab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 177Lu-DTPA-omburtamab
- description
- Intracerebroventricular administration of 177Lu-DTPA-omburtamab for up to five cycles.
- interventionNames
- Biological: radiolabeled DPTA-omburtamab
Primary outcomes (2)
- measure
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
- timeFrame
- 1 year
- description
- Safety will be evaluated by the incidence of AEs and SAEs graded according to CTCAE version 5.0. The maximum tolerated dose and the recommended phase 2 dose (RP2D) will be determined in Part 1
- measure
- Incidence of AEs and SAEs
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.