Advanced and Metastatic Solid TumorPhase 1NCT05914545
A Study of FZ-AD004 in Patients With Advanced Solid Tumors
A Phase 1 study testing FZ-AD004 in people with Advanced and Metastatic Solid Tumor, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced and Metastatic Solid Tumor
- What is being tested?
- FZ-AD004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 3 sitesChina
- Study dates
- 21 Jun 2023to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
Yongling Ji
Yongling Ji
- Recruiting
Shanghai Chest Hospital, Shanghai Jiaotong University, School of Medicine
Shanghai
Shun Lu
Shun Lu
- Recruiting
Hospital of Xuzhou Medical University
Xuzhou
Zhengxiang Han
Zhengxiang Han
About this study
Official title: 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.
Read the 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
- Being tested
- FZ-AD004
- Keywords
- Advanced and Metastatic Solid Tumor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FZ-AD004Drug
Also called FZ-AD004-Antibody-drug Conjugate
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: FZ-AD004 | Experimental | Participants enrolled in the dose escalation part or dose expansion part Receives: Drug: FZ-AD004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose limiting toxicity ( DLT)
To determine the dose limiting toxicities (DLTs) of FZ-AD004.
Measured: 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.
Measured: 21 Days (first cycle)
Adverse Events
To check the numbers of AEs happened during the course of trial.
Measured: 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.
Measured: From subject randomization up to 60 months.
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 17 weeks
Maximum observed plasma concentration (Cmax) of Total Antibody, Free DXd and FZ-AD004
- check what will be the maximum concentration participants will obtained of Total Antibody, Free DXd and FZ-AD004 in their blood plasma.
Measured: 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
Measured: 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
Measured: 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
Measured: From subject randomization up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start21 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced and Metastatic Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914545
- Sponsor's protocol ID
- F0040-101
- Status last verified
- Aug 2026
- First submitted
- 9 May 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05914545
- Acronym / sponsor ID
- F0040-101
- Conditions
- Advanced and Metastatic Solid Tumor
- Keywords
- Advanced and Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: FZ-AD004 | Experimental | Drug: FZ-AD004Participants enrolled in the dose escalation part or dose expansion part |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FZ-AD004Also: FZ-AD004-Antibody-drug ConjugateDose 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. | Drug | Experimental: FZ-AD004 |
Primary outcome
The dose limiting toxicity ( DLT)
Time frame: 21 Days (first cycle)
To determine the dose limiting toxicities (DLTs) of FZ-AD004.
Maximum Tolerable Dose (MTD)
Time frame: 21 Days (first cycle)
To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
Adverse Events
Time frame: Screening up to study completion
To check the numbers of AEs happened during the course of trial.
Objective Response Rate (ORR) according to RECIST 1.1
Time frame: From subject randomization up to 60 months.
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.
8 secondary outcomes
Progression free survival(PFS) according to RECIST 1.1
Time frame: From subject randomization up to 60 months.
Duration of Response(DOR) according to RECIST 1.1
Time frame: From subject randomization up to 60 months
Overall Survival (OS) according to RECIST 1.1
Time frame: From subject randomization up to 60 months.
Terminal elimination half-life (t1/2) of Total Antibody, Free DXd and FZ-AD004
Time frame: Up to 17 weeks
Maximum observed plasma concentration (Cmax) of Total Antibody, Free DXd and FZ-AD004
Time frame: 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
Time frame: Up to 17 weeks
Time to Cmax (Tmax) of Total Antibody, Free DXd and FZ-AD004
Time frame: Up to 17 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From subject randomization up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced and Metastatic Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FZ-AD004 in people with Advanced and Metastatic Solid Tumor, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuejing Cheng (00-86-021-58953355, xjcheng@fd-zj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose limiting toxicity ( DLT) (time frame: 21 Days (first cycle)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.