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

Advanced and Metastatic Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914545
• Other study ID #: F0040-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 12, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: Xuejing Cheng
• Phone: 00-86-021-58953355
• Email: xjcheng[@]fd-zj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 121
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced and Metastatic Solid Tumor
• Neoplasms

Intervention

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

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dose limiting toxicity ( DLT)	To determine the dose limiting toxicities (DLTs) of FZ-AD004.	21 Days (first cycle)
Primary	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)
Primary	Adverse Events	To check the numbers of AEs happened during the course of trial.	Screening up to study completion
Primary	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	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.
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	Area under the concentration-time curve (AUC 0-8) 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
Secondary	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
Secondary	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.