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

NCT ID: NCT05914545

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2027-12-31

Brief 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.

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.

Conditions

Advanced and Metastatic Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: FZ-AD004

Participants enrolled in the dose escalation part or dose expansion part

Group Type: EXPERIMENTAL

FZ-AD004

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

FZ-AD004-Antibody-drug Conjugate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Chest Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuejing Cheng

Role: CONTACT

xjcheng@fd-zj.com

00-86-021-58953355

Facility Contacts

Shun Lu

Role: primary

Other Identifiers

F0040-101

Identifier Type: -

Identifier Source: org_study_id