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OncoMatch/Clinical Trials/NCT06809517

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

Is NCT06809517 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including AK112 and Pemetrexed (Alimta) for leptomeningeal metastasis.

Phase 1/2RecruitingGuangzhou Medical UniversityNCT06809517Data as of May 2026

Treatment: AK112 · Pemetrexed (Alimta)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.

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Extracted eligibility criteria

Disease stage

Metastatic disease required

Leptomeningeal metastasis; Cerebrospinal fluid cytopathology is positive.

Prior therapy

Cannot have received: small molecule targeted therapy (EGFR-TKI, ALK-TKI, osimertinib, lorlatinib)

Exception: previously administered drugs are allowed

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.

Lab requirements

Blood counts

wbc≥4000/mm3, plt≥100000/mm3

Kidney function

normal kidney function

Liver function

normal liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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