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Intrathecal PD-1/VEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 20, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Lead sponsor: Zhenyu Pan to Guangzhou Medical Universityv3 Show 6 more changesShow less
    • Primary endpoints: 4 to 2
    • Start date changed from estimate of Sep 1, 2025 to Mar 18, 2025
    • Eligibility criteria revised
    • Secondary endpoints shortened, about 11 words
    • Study description expanded, about 35 words
    • Study title shortened, about 2 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 1, 2025 to Sep 1, 2025
    • Study sites: 0 to 1
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 PD-1/VEGF bispecific antibody plus pemetrexed in patients with leptomeningeal metastasis.
Trial Details
NCT Number NCT06809517
Lead Sponsor Guangzhou Medical University
Conditions
(from sponsor)		 Leptomeningeal Metastasis, Intrathecal Drug Delivery
Related terms Meningeal Carcinomatosis
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov