A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG) (NCT07455045) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG)
China40 participantsStarted 2026-03-01
Plain-language summary
An Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with HGG, especially in DMG and other Recurrent HGG.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily signed Informed Consent Form;
. Age 18-70 years, both male and female;
. Patients must be able to provide tumor tissue samples (archived tumor tissue within 2 years \[maximum 5 years\] or fresh core needle biopsy specimen, if possible) for DLL3 testing, with positive assessment results;
. Histopathologically confirmed high-grade glioma, classified according to WHO CNS5 2021 criteria, meeting one of the following characteristics:
. Prior treatment status:
. At least one measurable lesion at baseline (RANO 2.0 )
. Karnofsky Performance Status (KPS) score ≥70 (if patient has slightly lower score solely due to stable focal neurological deficits but can maintain basic daily living with support, 60 is approval);
. If patient is receiving corticosteroids for tumor-related cerebral edema or neurological symptoms, dosage must be stable or decreasing for at least 7 days prior to baseline MRI, with dose ≤5 mg/day dexamethasone (or equivalent dose of other corticosteroids); if increased steroid dosage is required during screening to control cerebral edema due to clinical deterioration, the patient is ineligible;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerable Dose (MTD)
Timeframe: Screening up to study completion, assessed up to 36 months
2
The dose limiting toxicity ( DLT)
Timeframe: 21 Days (first cycle)
3
Adverse Events (AEs）
Timeframe: Screening up to study completion, assessed up to 36 months
. Prior treatment with other anti-DLL3 targeted antibody therapies or other DLL3-directed treatments, or ADC drugs containing DXd payload;
. History of allergic reaction to exatecan or ≥Grade 3 gastrointestinal toxicity following prior exatecan use, or hypersensitivity to protein components structurally similar to FZ-AD005, or hypersensitivity to excipients of the FZ-AD005 investigational drug;
. Subjects with any contraindications to magnetic resonance imaging (MRI) (e.g., cardiac pacemaker, non-removable metal implants, etc.);
. History of other malignancies within the past 3 years (except for specific low-risk tumors that have been radically treated);
. Failure to meet the following washout period requirements prior to first dose:
. Receipt of live vaccine within 4 weeks prior to first dose;
. Active infection requiring drug intervention within 2 weeks prior to first dose, or unexplained fever \>38°C with elevated procalcitonin results between screening and first dose (subjects with tumor-related fever may be enrolled at investigator's discretion);
. Severe mass effect or risk of brain herniation, defined as: baseline MRI showing midline shift \>5 mm, or signs of uncontrolled intracranial hypertension/hydrocephalus; or investigator's judgment that the patient cannot tolerate any degree of treatment-induced cerebral edema;