Treatment for leptomeningeal metastasis using a bispecific antibody and chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I/II clinical trial evaluates the safety, feasibility, and therapeutic response of an intrathecal PD-1/VEGF bispecific antibody combined with pemetrexed in patients suffering from leptomeningeal metastasis. The study aims to determine the recommended dosage of the bispecific antibody, ivonescimab, and assess its effectiveness in improving clinical outcomes such as progression-free survival and overall survival. Participants will undergo cerebrospinal fluid and blood specimen collection to identify potential predictors of treatment efficacy and safety. The trial builds on preliminary findings suggesting that this combination therapy may offer a new approach to treating this severe complication of advanced malignancies.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Affiliated Huizhou Hospital, Guangzhou Medical University
  Huizhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Zhenyu Pan, PhD,MD — The Affiliated HuizhouHospital, Guangzhou Medical University
• Study coordinator: Zhenyu Pan, PhD, MD
• Email: dr-zypan@163.com
• Phone: +8618718178286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pulsatile high-dose furmonertinib for EGFR-mutant NSCLC with leptomeningeal metastasis

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• Multiple intraventricular doses of rhenium‑186 nanoliposome for leptomeningeal metastases

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• High-dose firmonertinib plus chemotherapy injected into the spinal fluid for EGFR-mutant NSCLC with leptomeningeal spread

  This tests whether high-dose firmonertinib combined with chemotherapy injected into the spinal fluid helps people with EGFR-mutant non-small cell lung cancer that has spread to the leptomeninges.

  Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07092202

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.