NCT05914545

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_1

Timeline
17mo left

Started Jun 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jun 2023Dec 2027

First Submitted

Initial submission to the registry

May 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

May 9, 2023

Last Update Submit

January 20, 2026

Conditions

Advanced and Metastatic Solid Tumor

Keywords

Advanced and Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • Progression free survival(PFS) according to RECIST 1.1

    From subject randomization up to 60 months.

  • Duration of Response(DOR) according to RECIST 1.1

    From subject randomization up to 60 months

  • Overall Survival (OS) according to RECIST 1.1

    From subject randomization up to 60 months.

  • Terminal elimination half-life (t1/2) of Total Antibody, Free DXd and FZ-AD004

    Up to 17 weeks

  • Maximum observed plasma concentration (Cmax) of Total Antibody, Free DXd and FZ-AD004

    Up to 17 weeks

  • +3 more secondary outcomes

Study Arms (1)

Experimental: FZ-AD004

EXPERIMENTAL

Participants enrolled in the dose escalation part or dose expansion part

Drug: FZ-AD004

Interventions

FZ-AD004DRUG

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.

Also known as: FZ-AD004-Antibody-drug Conjugate
Experimental: FZ-AD004

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients able to give written informed consent;
  • Age ≥ 18 and ≤ 75 years old, male or female;
  • Patients have histological or cytological diagnosis with advanced solid tumors.
  • Have measurable lesions defined in RECIST v. 1.1;
  • Expected survival ≥ 12 weeks;
  • Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
  • Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

You may not qualify if:

  • Have had other malignant tumors in the past 5 years;
  • Have CNS (central nervous system) metastasis with clinical symptoms;
  • Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
  • Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
  • Have history of psychotropic drug abuse, alcohol or drug abuse；
  • Women who are pregnant or lactating；
  • Other circumstances that is deemed not appropriate for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xuejing Cheng

CONTACT

00-86-021-58953355xjcheng@fd-zj.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 22, 2023

Study Start

June 12, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)