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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 (Jun 2026). This Phase 1/2 trial studies multiple treatments including AK112 and Pemetrexed (Alimta) for leptomeningeal metastasis.

Phase 1/2RecruitingGuangzhou Medical UniversityNCT06809517Data as of Jun 2026Location: China

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

Treatments studied

Other

AK112Pemetrexed (Alimta)

Disease stage

Metastatic disease required

Leptomeningeal metastasis; Cerebrospinal fluid cytopathology is positive.

Demographics

Ages 21–75

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.

Frequently asked questions

Is NCT06809517 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior small molecule targeted therapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger and at least 21 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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