Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT05914545

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

Led by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Updated on 2026-01-22

121

Participants Needed

1

Research Sites

233 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to give written informed consent
  • Age 18 to 75 years, male or female
  • Diagnosed with advanced solid tumors by histology or cytology
  • Have measurable lesions defined by RECIST v. 1.1
  • Expected survival of at least 12 weeks
  • Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
  • Patients of childbearing potential must agree to use contraception during the study and for 6 months after treatment ends
Not Eligible

You will not qualify if you...

  • History of other malignant tumors within the past 5 years
  • Central nervous system metastasis with clinical symptoms
  • Major surgery or severe trauma within 4 weeks before first dose
  • Systemic high-dose steroids within 2 weeks before starting study treatment
  • History of psychotropic drug abuse, alcohol or drug abuse
  • Women who are pregnant or breastfeeding
  • Any other condition that makes participation unsuitable according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Chest Hospital

Shanghai, China

Actively Recruiting

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Research Team

X

Xuejing Cheng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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