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Clinical Trials in China / NCT05914545
Recruiting Phase 1

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

NCT05914545 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd
Phase
Phase 1
Started
2023-06-21
Last updated
2026-08-28

Condition(s) studied

Advanced and Metastatic Solid Tumor

Investigational drug(s) / intervention(s)

FZ-AD004

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The dose limiting toxicity ( DLT) — 21 Days (first cycle)
    To determine the dose limiting toxicities (DLTs) of FZ-AD004.
  • Maximum Tolerable Dose (MTD) — 21 Days (first cycle)
    To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
  • Adverse Events — Screening up to study completion
    To check the numbers of AEs happened during the course of trial.
  • Objective Response Rate (ORR) according to RECIST 1.1 — From subject randomization up to 60 months.
    To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD004 when administered intravenously (IV) as monotherapy at the RDEs to patients with metastatic or locally advanced unresectable tumors.

Trial sites (3)

FacilityCityRegionStatus
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

More Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. trials in China

A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG) Starting soon
A Study of FDA018-ADC in Patients With Advanced Solid Tumors Active, not recruiting
FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Active, not recruiting
A Study of FZ-AD005 in Patients With Advanced Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05914545 on ClinicalTrials.gov ↗ ← All trials in China