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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later across 2 updates Jul 30, 2026 → Oct 30, 2026
See other at-risk trials from Guangzhou Medical University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Oct 30, 2026
    • Enrollment target: 36 to 39
    • Eligibility criteria expanded, about 8 words
    • Publications: details revised at 2 of 2 entries
  2. Primary and study completion pushed from Jul 30, 2026 to Sep 30, 2026
    • Study sites: 2 to 3
    • Study description shortened, about 3 words
    • Collaborators expanded, about 4 words
    v6
  3. Primary completion date: Jan 1, 2026 to Jul 30, 2026v5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 1 to 2
    • Study completion date: Jun 1, 2026 to Jul 30, 2026
    • Eligibility criteria revised
  4. Primary endpoints: 3 to 2
    • Eligibility criteria revised
    • Secondary endpoints shortened, about 13 words
    • Study description expanded, about 45 words
    v4
  5. Start date changed from estimate of Apr 1, 2025 to Mar 7, 2025v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Feb 1, 2025 to Apr 1, 2025
    • Primary endpoints revised (3)
    • Study sites: 0 to 1
    • Study title expanded, about 6 words
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) bispecific antibodies combined with pemetrexed in patients with leptomeningeal metastasis.
Trial Details
NCT Number NCT06762080
Lead Sponsor Guangzhou Medical University
Collaborators: Jinshan Hospital Fudan University
Conditions
(from sponsor)		 Leptomeningeal Metastasis
Related terms Meningeal Carcinomatosis
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov