A Study of FZ-AD004 in Patients with Advanced Solid Tumors

Launched by SHANGHAI FUDAN-ZHANGJIANG BIO-PHARMACEUTICAL CO., LTD. · Jun 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called FZ-AD004 in patients who have advanced solid tumors, which are cancers that have spread beyond their original site. This is the first time this drug is being tested in humans, and the trial has two parts: one to find the right dose of the drug (called Dose Escalation) and another to see how well it works at that dose (called Dose Expansion). The main goals are to check how safe the drug is, how it moves through the body, and if it helps improve the condition.

To be eligible for this study, participants must be between 18 and 75 years old, able to provide consent, and have a confirmed diagnosis of advanced solid tumors that can be measured. They should be expected to survive for at least 12 weeks and be in good enough health to take part in the study. Participants can expect to be closely monitored throughout the trial for any side effects and to see how effective the treatment is. It's important to note that some people may not qualify, such as those who have had other cancers recently or certain medical conditions. If you're interested, please discuss it with your healthcare provider for more information.

Gender

ALL

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.