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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
FZ-AD005
DrugEvery 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: FZ-AD005Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerable Dose (MTD)
To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Time frame
Screening up to study completion, assessed up to 36 months2
The dose limiting toxicity ( DLT)
To determine the dose limiting toxicities (DLTs) of FZ-AD005
Time frame
21 Days (first cycle)3
Adverse Events (AEs）
To check the numbers of AEs happened during the course of trial.
Time frame
Screening up to study completion, assessed up to 36 months4
Disease control rate(DCR)
To evaluate the \[Complete Response (CR) + Partial Response (PR)+ Stable Disease\] of FZ-AD005 according to RANO 2.0
Time frame
Up to 36 monthsSecondary outcomes
1
Objective Response Rate (ORR)
To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD005 according to RANO 2.0
Time frame
Up to 12 months2
Progression free survival(PFS)
Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
Time frame
Up to 36 months3
Duration of Response(DOR)
Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Time frame
Up to 36 months4
Overall Survival (OS)
overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause
Time frame
Up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: