A Study of FZ-AD005 in Patients With Advanced Solid Tumors (NCT06424665) | Clinical Trial Compass
RecruitingPhase 1
A Study of FZ-AD005 in Patients With Advanced Solid Tumors
China162 participantsStarted 2024-07-03
Plain-language summary
A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients able to give written informed consent;
✓. Age ≥ 18 and ≤ 75 years old, male or female;
✓. Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);
✓. Willingness to provide tumor tissue for testing ;
✓. Have measurable lesions defined in RECIST v. 1.1;
✓. Expected survival ≥ 3 months;
✓. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
✓. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.
Exclusion criteria
✕. Patients who have had previous treatment with any anti-DLL3 antibody；
✕. Have had other malignant tumors in the past 5 years;
✕. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
✕. Have active CNS (central nervous system) metastasis；
✕. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
✕
What they're measuring
1
The dose limiting toxicity ( DLT)
Timeframe: 21 Days (first cycle)
2
Maximum Tolerable Dose (MTD)
Timeframe: 21 Days (first cycle)
3
Adverse Events (AEs）
Timeframe: Screening up to study completion, assessed up to 60 months