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 range18 Years β 70 Years
SexALL
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Inclusion criteria
β. Voluntarily signed Informed Consent Form;
β. Age 18-70 years, both male and female;
β. 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;
β. Histopathologically confirmed high-grade glioma, classified according to WHO CNS5 2021 criteria, meeting one of the following characteristics:
β. Prior treatment status:
β. At least one measurable lesion at baseline (RANO 2.0 )
β. Karnofsky Performance Status (KPS) score β₯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);
β. 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 β€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
β. Prior treatment with other anti-DLL3 targeted antibody therapies or other DLL3-directed treatments, or ADC drugs containing DXd payload;
β. History of allergic reaction to exatecan or β₯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;
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 (AEsοΌ
Timeframe: Screening up to study completion, assessed up to 36 months
β. Subjects with any contraindications to magnetic resonance imaging (MRI) (e.g., cardiac pacemaker, non-removable metal implants, etc.);
β. History of other malignancies within the past 3 years (except for specific low-risk tumors that have been radically treated);
β. Failure to meet the following washout period requirements prior to first dose:
β. Receipt of live vaccine within 4 weeks prior to first dose;
β. Active infection requiring drug intervention within 2 weeks prior to first dose, or unexplained fever \>38Β°C with elevated procalcitonin results between screening and first dose (subjects with tumor-related fever may be enrolled at investigator's discretion);
β. 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;