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OncoMatch/Clinical Trials/NCT06762080

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

Is NCT06762080 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Cadonilimab (AK104) and Pemetrexed (Alimta) for leptomeningeal metastasis.

Phase 1/2RecruitingGuangzhou Medical UniversityNCT06762080Data as of May 2026

Treatment: Cadonilimab (AK104) · 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 Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) bispecific antibodies combined with 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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