Clinical Trial

Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated July 21, 2026 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Leptomeningeal metastasis, characterized by tumor cells infiltrating and proliferating in the subarachnoid space, represents a distinct pattern of central nervous system involvement and is a fatal complication of malignant tumors. This phase I/II study is to evaluate the recommended dose, safety, feasibility, and therapeutic response of intrathecal Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) bispecific antibodies combined with pemetrexed in patients with leptomeningeal metastasis.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-01-01; most recent amendment 2026-07-19.
Status change: Recruiting → Active, Not Recruiting 2026-07-19
Status change: Not Yet Recruiting → Recruiting 2025-03-18
Trial Details
NCT Number NCT06762080
Lead Sponsor Guangzhou Medical University
Conditions Leptomeningeal Metastasis
Enrollment 36 participants
Start Date 2025-03-07
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-21