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Trial Title:
A Study of FZ-AD004 in Patients with Advanced Solid Tumors
NCT ID:
NCT05914545
Condition:
Advanced and Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Immunoconjugates
Conditions: Keywords:
Advanced and Metastatic Solid Tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FZ-AD004
Description:
Dose Escalation：Subjects will receive an intravenous infusion of FZ-AD004 in a dose
escalation until confirmed progression, unaccepted toxicity, or any criterion for
withdrawal from the study.
Dose Expansion：Subject will receive a single dose of FZ-AD004 at 1-2 dose level on Day1
of each cycles.
Arm group label:
Experimental: FZ-AD004
Other name:
FZ-AD004-Antibody-drug Conjugate
Summary:
This study is one single group of participants with advanced solid tumors. It is the
first time the drug has been used in humans. There will be two parts including Dose
Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and
clinical activity of FZ-AD004.
Detailed description:
This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion
study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of
FZ-AD004 in patients with advanced/metastatic solid tumors. FZ-AD004 is administered via
intravenous infusion using an accelerated titration method followed by a conventional 3 +
3 study design to identify the maximum tolerated dose (MTD) and dose-limiting
toxicities（DLT）during cycle 1. In addition, the maximum-tolerated dose and recommended
Phase II dose for FZ-AD004 will be determined.
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.
4. Have measurable lesions defined in RECIST v. 1.1;
5. Expected survival ≥ 12 weeks;
6. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
7. 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. Have had other malignant tumors in the past 5 years;
2. Have CNS (central nervous system) metastasis with clinical symptoms;
3. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
4. Had undergone systemic high-dose steroids within 2 weeks of initiation of study
treatment;
5. Have history of psychotropic drug abuse, alcohol or drug abuse；
6. Women who are pregnant or lactating；
7. Other circumstances that is deemed not appropriate for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu
Start date:
June 12, 2023
Completion date:
December 2025
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/NCT05914545
