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RECRUITING
NCT05914545
PHASE1

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

Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2023-06-12

Completion Date

2027-12

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, China