Clinical trial
A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients With Advanced Solid Tumors
Name
F0040-101
Description
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.
Trial arms
Trial start
2023-06-12
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
FZ-AD004
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.
Arms:
Experimental: FZ-AD004
Other names:
FZ-AD004-Antibody-drug Conjugate
Size
121
Primary endpoint
The dose limiting toxicity ( DLT)
21 Days (first cycle)
Maximum Tolerable Dose (MTD)
21 Days (first cycle)
Adverse Events
Screening up to study completion
Objective Response Rate (ORR) according to RECIST 1.1
From subject randomization up to 60 months.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 121, 'type': 'ESTIMATED'}}
Updated at
2023-06-22
1 organization
1 product
1 indication
Organization
Shanghai Fudan-Zhangjiang Bio-PharmaceuticalProduct
FZ-AD004Indication
Solid Tumor