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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced and Metastatic Solid Tumor
• Intervention / Treatment: Drug: FZ-AD004

Detailed Description

This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FZ-AD004 in patients with advanced/metastatic solid tumors. FZ-AD004 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）during cycle 1. In addition, the maximum-tolerated dose and recommended Phase II dose for FZ-AD004 will be determined.

• Study Type: Interventional
• Enrollment (Estimated): 121
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xuejing Cheng; Phone Number: 00-86-021-58953355; Email: xjcheng@fd-zj.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Chest Hospital
    • Principal Investigator: Shun Lu
    • Contact: Shun Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: FZ-AD004; Participants enrolled in the dose escalation part or dose expansion part	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.; Other Names: FZ-AD004-Antibody-drug Conjugate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dose limiting toxicity ( DLT)	To determine the dose limiting toxicities (DLTs) of FZ-AD004.	21 Days (first cycle)
Maximum Tolerable Dose (MTD)	To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.	21 Days (first cycle)
Adverse Events	To check the numbers of AEs happened during the course of trial.	Screening up to study completion
Objective Response Rate (ORR) according to RECIST 1.1	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.	From subject randomization up to 60 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival(PFS) according to RECIST 1.1	Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.	From subject randomization up to 60 months.
Overall Survival (OS) according to RECIST 1.1	Overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause.	From subject randomization up to 60 months.
Duration of Response(DOR) according to RECIST 1.1	Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).	From subject randomization up to 60 months
Terminal elimination half-life (t1/2) of Total Antibody, Free DXd and FZ-AD004	To check how much time Total Antibody, Free DXd and FZ-AD004 will take to eliminate half of it's concentration from participants.	Up to 17 weeks
Maximum observed plasma concentration (Cmax) of Total Antibody, Free DXd and FZ-AD004	o check what will be the maximum concentration participants will obtained of Total Antibody, Free DXd and FZ-AD004 in their blood plasma.	Up to 17 weeks
Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of Total Antibody, Free DXd and FZ-AD004	To check the drug profile for absorption, distribution, metabolism and excretion for Total Antibody, Free DXd and FZ-AD004 in participants blood plasma	Up to 17 weeks
Time to Cmax (Tmax) of Total Antibody, Free DXd and FZ-AD004	To check what time will it take to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD004 in study participants	Up to 17 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)	To check the" Anti Drug Antibody" develops in participants against the FZ-AD004 through blood sample	From subject randomization up to 60 months.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Advanced and Metastatic Solid Tumor
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Physiological Effects of Drugs; Immunologic Factors; Immunoconjugates
• Other Study ID Numbers: F0040-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No