Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)Phase 1NCT06424665

A Study of FZ-AD005 in Patients With Advanced Solid Tumors

A Phase 1 study testing FZ-AD005 in people with Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma), run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
What is being tested?: FZ-AD005
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 3 sitesChina
Study dates: 3 Jul 2024to 1 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 ( especially SCLC or LCNEC);
Willingness to provide tumor tissue for testing ;
Have measurable lesions defined in RECIST v. 1.1;
Expected survival ≥ 3 months;
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

Patients who have had previous treatment with any anti-DLL3 antibody；
Have had other malignant tumors in the past 5 years;
Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
Have active CNS (central nervous system) metastasis；
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;

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Patients have psychiatric history;
Female patients who are breastfeeding or pregnant;
Other reasons that researchers believe are inappropriate to participate in this study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mengli Zhou contact

00-86-021-58953355

mlzhou@fd-zj.com

China3 sites, 3 recruiting

Hunan Cancer Hospital
Changsha, Hunan, 410013
Lin Wu
Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song
Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Caicun Zhou
Recruiting

Other trials in China

About this study

Official title: A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors

A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.

Conditions: Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
Being tested: FZ-AD005
Medical subject headings: Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FZ-AD005Drug
Every 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Study groups in NCT06424665
Study group	Role	What they receive
FZ-AD005	Experimental	Not described Receives: Drug: FZ-AD005

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-AD005
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 (AEs）
To check the numbers of AEs happened during the course of trial.
Measured: Screening up to study completion, assessed up to 60 months
Objective Response Rate (ORR)
To evaluate the objective response rate (ORR) [Complete Response (CR) + Partial Response (PR)] of FZ-AD005 according to RECIST 1.1
Measured: Up to 60 months

Secondary outcomes (9)

Progression free survival(PFS)
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: Up to 60 months
Duration of Response(DOR)
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: Up to 60 months
Overall Survival (OS)
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: Up to 60 months
Anti Drug Antibody (ADA)
To check the" Anti Drug Antibody" develops in participants against the FZ-AD005 through blood sample
Measured: Up to 36 months
Time to peak (Tmax)
To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants
Measured: Up to 18 weeks
Terminal elimination half-life (t1/2)
To measure the time of Total Antibody, Free DXd and FZ-AD005 will take to eliminate half of it's concentration from participants.
Measured: Up to 18 weeks
Maximum observed plasma concentration (Cmax)
To measure the maximum concentration participants obtained of Total Antibody, Free DXd and FZ-AD004 in their blood plasma.
Measured: Up to 18 weeks
Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity
To measure the drug profile for absorption, distribution, metabolism and excretion for Total Antibody, Free DXd and FZ-AD005 in participants blood plasma
Measured: Up to 18 weeks
Time to Cmax (Tmax)
To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants
Measured: Up to 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 20241 Dec 2027

First posted22 May 2024
Study start3 Jul 2024
Primary completion1 Aug 2026 (estimated)
Study completion1 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)Studies 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: Single group
Masking: None (open label)
Enrolment: 162 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06424665
Sponsor's protocol ID: F0041-101
Status last verified: Jan 2026
First submitted: 12 May 2024
Last updated: 4 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 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-AD005 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06424665
Acronym / sponsor ID: F0041-101
Conditions: Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 162 participants (estimated)
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 Jul 2024 (actual)
Primary completion: 1 Aug 2026 (estimated)
Study completion: 1 Dec 2027 (estimated)
First posted: 22 May 2024 (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.

A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FZ-AD005	Experimental	Drug: FZ-AD005

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 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 ( especially SCLC or LCNEC);
Willingness to provide tumor tissue for testing ;
Have measurable lesions defined in RECIST v. 1.1;

Key exclusion criteria (9 listed)

Patients who have had previous treatment with any anti-DLL3 antibody；
Have had other malignant tumors in the past 5 years;
Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
Have active CNS (central nervous system) metastasis；
Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;

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-AD005Every 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.	Drug	FZ-AD005

Primary outcome

The dose limiting toxicity ( DLT)
Time frame: 21 Days (first cycle)
To determine the dose limiting toxicities (DLTs) of FZ-AD005
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 (AEs）
Time frame: Screening up to study completion, assessed up to 60 months
To check the numbers of AEs happened during the course of trial.
Objective Response Rate (ORR)
Time frame: Up to 60 months
To evaluate the objective response rate (ORR) [Complete Response (CR) + Partial Response (PR)] of FZ-AD005 according to RECIST 1.1

9 secondary outcomes

Progression free survival(PFS)
Time frame: Up to 60 months
Duration of Response(DOR)
Time frame: Up to 60 months
Overall Survival (OS)
Time frame: Up to 60 months
Anti Drug Antibody (ADA)
Time frame: Up to 36 months
Time to peak (Tmax)
Time frame: Up to 18 weeks
Terminal elimination half-life (t1/2)
Time frame: Up to 18 weeks
Maximum observed plasma concentration (Cmax)
Time frame: Up to 18 weeks
Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity
Time frame: Up to 18 weeks
Time to Cmax (Tmax)
Time frame: Up to 18 weeks

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 4 Mar 2026.

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.

Mengli Zhou contact

00-86-021-58953355

mlzhou@fd-zj.com

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 9 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 4 Mar 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 Mengli Zhou (00-86-021-58953355, mlzhou@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?

On the ClinicalTrials.gov record for NCT06424665.

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 4 Mar 2026.