A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
At least one measurable lesion at baseline (RANO 2.0 )
Disqualifiers
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);
Trial design
Treatments tested in this trial
- FZ-AD005
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov