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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

2015-09: a Phase II Randomized, Open-label Study of Anti-signaling Lymphocytic Activation Molecule Monoclonal Antibody During Maintenance Therapy

NCT03000634

Multiple Myeloma

WITHDRAWN PHASE2

Pembrolizumab in Patients With Leptomeningeal Disease

NCT03091478

Patients With Leptomeningeal Disease

TERMINATED PHASE2

Testing an Anti-cancer Radio-Active Immunotherapy Called Lintuzumab Ac225 in Patients With High-Risk Myelodysplastic Syndrome That Has Not Responded to Other Treatment

NCT06888323

Refractory Myelodysplastic Syndrome

SUSPENDED PHASE1

Belantamab Mafodotin, Lenalidomide, and Daratumumab for the Treatment of Relapsed, Refractory, or Previously Untreated Multiple Myeloma

NCT04892264

Plasma Cell Myeloma Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma

TERMINATED PHASE1

T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant

NCT00048464

Multiple Myeloma

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 intracerebroventricular 177Lu-DTPA-omburtamab.

Part 2 is a cohort-expansion phase in which patients will receive a treatment at the recommended dose determined in Part 1, until confirmed LM progression, unacceptable toxicity, or for maximum of 5 cycles, whichever comes first; however, the total number of cycles will be determined based upon data from Part 1 (e.g., the dosimetry data) to minimize the risk of radiation necrosis and decreased neurological function End of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. The patients will be followed for up until one year after first dose (Part 1) and 2 years after first dose (Part 2).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leptomeningeal Metastasis Solid Tumor, Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients will receive up to five cycles of intracerebroventricular 177Lu-DTPA-omburtamab. Safety and efficacy will be investigated during treatment and follow-up period.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

177Lu-DTPA-omburtamab

Intracerebroventricular administration of 177Lu-DTPA-omburtamab for up to five cycles.

Group Type EXPERIMENTAL

radiolabeled DPTA-omburtamab

Intervention Type BIOLOGICAL

Biological, radiolabeled DPTA-omburtamab

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radiolabeled DPTA-omburtamab

Biological, radiolabeled DPTA-omburtamab

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Drug: 177Lu-DTPA-omburtamab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No