Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06424665

A Study of FZ-AD005 in Patients With Advanced Solid Tumors

Led by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Updated on 2026-03-04

162

Participants Needed

3

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.

CONDITIONS

Official Title

A Study of FZ-AD005 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients able to give written informed consent
  • Age 18 to 75 years, male or female
  • Diagnosed with advanced solid tumors, especially Small Cell Lung Cancer or Large Cell Neuroendocrine Carcinoma
  • Willing to provide tumor tissue for testing
  • Have measurable lesions defined by RECIST v1.1
  • Expected survival of at least 3 months
  • Eastern Cooperative Oncology 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
Not Eligible

You will not qualify if you...

  • Previous treatment with any anti-DLL3 antibody
  • History of other malignant tumors within the past 5 years
  • Receiving other anti-tumor treatments within 4 weeks before the first dose
  • Active central nervous system metastasis
  • Major surgery or severe trauma within 4 weeks before the first dose
  • Systemic high-dose steroids within 2 weeks before starting study treatment
  • History of psychiatric illness
  • Female patients who are breastfeeding or pregnant
  • Any other reasons deemed inappropriate by the researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Actively Recruiting

2

Shanghai East Hospital

Shanghai, Shanghai Municipality, China, 200120

Actively Recruiting

3

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

Loading map...

Research Team

M

Mengli Zhou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

A Study of FZ-AD005 in Patients With Advanced Solid Tumors | DecenTrialz