A Study of FZ-AD005 in Patients With Advanced Solid Tumors
Recruiting · NCT06424665 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
FZ-AD005
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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;
- Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
- Patients have psychiatric history;
- Female patients who are breastfeeding or pregnant;
- Other reasons that researchers believe are inappropriate to participate in this study.
Where it is running
3 locations listed.
- Hunan Cancer Hospital - Changsha, Hunan, China
- Shanghai East Hospital - Shanghai, Shanghai Municipality, China
- Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China