A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors

F0041-101

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.

2024-05-30

2025-12-01

2026-06-01

Not yet recruiting

Early phase I

162

Inclusion Criteria: 1. Patients able to give written informed consent; 2. Age ≥ 18 and ≤ 75 years old, male or female; 3. Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC); 4. Willingness to provide tumor tissue for testing ; 5. Have measurable lesions defined in RECIST v. 1.1; 6. Expected survival ≥ 3 months; 7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1; 8. 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: 1. Patients who have had previous treatment with any anti-DLL3 antibody； 2. Have had other malignant tumors in the past 5 years; 3. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose; 4. Have active CNS (central nervous system) metastasis； 5. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose; 6. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment; 7. Patients have psychiatric history; 8. Female patients who are breastfeeding or pregnant; 9. Other reasons that researchers believe are inappropriate to participate in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 162, 'type': 'ESTIMATED'}}

2024-05-22