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Trial Title:
A Study of FZ-AD005 in Patients With Advanced Solid Tumors
NCT ID:
NCT06424665
Condition:
Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
Conditions: Official terms:
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FZ-AD005
Description:
Every 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.
Arm group label:
FZ-AD005
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Wu
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Recruiting
Contact:
Last name:
Caicun Zhou
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengbo Song
Start date:
July 3, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06424665
