Testing FZ-AD004 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, Phase 1 clinical trial evaluating the safety and efficacy of FZ-AD004 in patients with advanced or metastatic solid tumors. The study consists of two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to further assess the drug's effects. Participants will receive FZ-AD004 via intravenous infusion, and the study will monitor pharmacokinetics and clinical activity. The trial aims to provide insights into the drug's tolerability and potential therapeutic benefits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, China Recruiting
• Shanghai Chest Hospital, Shanghai Jiaotong University, School of Medicine
  Shanghai, China Recruiting
• Hospital of Xuzhou Medical University
  Xuzhou, China Recruiting

Study contacts

• Study coordinator: Xuejing Cheng
• Email: xjcheng@fd-zj.com
• Phone: 00-86-021-58953355

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating FZ-AD005 for patients with advanced solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.