Actively Recruiting
A Study of FZ-AD005 in Patients With Advanced Solid Tumors
Led by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Updated on 2026-03-04
162
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of FZ-AD005 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients able to give written informed consent
- Age 18 to 75 years, male or female
- Diagnosed with advanced solid tumors, especially Small Cell Lung Cancer or Large Cell Neuroendocrine Carcinoma
- Willing to provide tumor tissue for testing
- Have measurable lesions defined by RECIST v1.1
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients of childbearing potential must agree to use contraception during the study and for 6 months after treatment
You will not qualify if you...
- Previous treatment with any anti-DLL3 antibody
- History of other malignant tumors within the past 5 years
- Receiving other anti-tumor treatments within 4 weeks before the first dose
- Active central nervous system metastasis
- Major surgery or severe trauma within 4 weeks before the first dose
- Systemic high-dose steroids within 2 weeks before starting study treatment
- History of psychiatric illness
- Female patients who are breastfeeding or pregnant
- Any other reasons deemed inappropriate by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
M
Mengli Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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