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Clinical Trial Summary

To determine the safety of intrathecal (IT) PD1 antibody for Intrathecal application of PD1 antibody in metastatic solid tumors with leptomeningeal disease of solid tumors.


Clinical Trial Description

Leptmeningeal disease (LMD) is an aggressive subtype of metastatic disease in the central nervous system (CNS) and has a poor prognosis with a median overall survival of a few months.The IT-PD1 trial group wants to contribute to an improvement of this situation for LMD patients by using an intrathecal application route for the PD1 antibody, i.e. a drug that has shown clinical efficacy in the underlying tumor via the intravenous route. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05112549
Study type Interventional
Source University Hospital Tuebingen
Contact Ghazaleh Tabatabai, Prof.Dr.
Phone +49 (0) 7071 - 2985018
Email ghazaleh.tabatabai@uni-tuebingen.de
Status Recruiting
Phase Phase 1
Start date October 12, 2021
Completion date September 30, 2026

See also
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Terminated NCT03711422 - Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC Phase 1
Recruiting NCT02422641 - Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis Phase 2
Active, not recruiting NCT03719768 - Avelumab With Radiotherapy in Patients With Leptomeningeal Disease Phase 1
Not yet recruiting NCT06146010 - Non Interventional German Leptomeningeal Disease Register
Active, not recruiting NCT03501979 - Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD Phase 2
Recruiting NCT05800275 - Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease Phase 2
Recruiting NCT04588545 - Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease Phase 1/Phase 2
Recruiting NCT05809752 - A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Phase 1