NCT06809517 Intrathecal PD-1/VEGF Bispecific Antibody Plus Pemetrexed for Leptomeningeal Metastasis
| NCT ID | NCT06809517 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Guangzhou Medical University |
| Condition | Leptomeningeal Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 34 participants in total. It began in 2025-03-18 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 PD-1/VEGF bispecific antibody plus pemetrexed in patients with leptomeningeal metastasis.
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of solid tumors;Cerebrospinal fluid cytopathology is positive. 2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3. 3. No history of severe nervous system disease; No severe dyscrasia. Exclusion Criteria: 1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11. 2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment. 3. Obvious bleeding tendency; Patients with hemorrhage (NCI-CTCAE v5.0 greater than grade 2), coagulation disorder, hypertensive crisis, and severe arterial thrombosis. 4. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years. 5. The first month to treatment, as well as during induction and consolidation therapy, new drugs effective against leptomeningeal metastases were used, excluding those previously administered. These primarily included small molecule targeted therapies, such as EGFR-TKI/ALK-TKI drugs like Osimertinib and Lorlatinib. 6. Patients with poor compliance or other reasons that were unsuitable for this study.
Contact & Investigator
Zhenyu Pan, PhD,MD
PRINCIPAL INVESTIGATOR
The Affiliated HuizhouHospital, Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT06809517 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Leptomeningeal Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06809517 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06809517 currently recruiting?
Yes, NCT06809517 is actively recruiting participants. Contact the research team at dr-zypan@163.com for enrollment information.
Where is the NCT06809517 trial being conducted?
This trial is being conducted at Huizhou, China.
Who is sponsoring the NCT06809517 clinical trial?
NCT06809517 is sponsored by Guangzhou Medical University. The principal investigator is Zhenyu Pan, PhD,MD at The Affiliated HuizhouHospital, Guangzhou Medical University. The trial plans to enroll 34 participants.