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Spinal fluid injection of Dual-Target antibody and chemotherapy shows promise for deadly cancer complication

NCT ID NCT06762080

Disease control Sponsor: Guangzhou Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This phase I/II trial tests a combination of two drugs injected directly into the spinal fluid for people with leptomeningeal metastasis, a condition where cancer spreads to the membranes surrounding the brain and spinal cord. The drugs are a bispecific antibody (cadonilimab) that targets two immune checkpoints (PD-1 and CTLA-4) and the chemotherapy drug pemetrexed. The study aims to find the safest dose and evaluate whether this treatment can control the disease in patients with solid tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a bispecific antibody (cadonilimab) that targets PD-1 and CTLA-4, combined with the chemotherapy drug pemetrexed, both injected into the spinal fluid
What this could lead to
If successful, this approach could offer a new treatment option for leptomeningeal metastasis, a fatal complication of cancer that currently has few effective therapies.
What could go wrong
This is an early-phase trial with only 36 participants, so the benefits are uncertain. The treatment involves direct injection into the spinal fluid and carries risks of serious neurological side effects like chemical meningitis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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. 4. 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. 5. Patients with poor compliance or other reasons that were unsuitable for this study.

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Conditions

The condition(s) this trial relates to.

Meningeal Carcinomatosis neoplastic meningitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leptomeningeal metastasis

Contacts and locations

Locations

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101100, China

  • Jinshan Hospital, Fudan University

    Shanghai, China

  • The Affiliated Huizhou Hospital, Guangzhou Medical University

    Huizhou, Guangdong, 516000, China

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