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New hope for advanced cancer: first human trial of FZ-AD004 begins

NCT ID NCT05914545

Disease control Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tests a new drug, FZ-AD004, for the first time in people with advanced solid tumors that have spread or cannot be removed. The goal is to find a safe dose and see if it can shrink tumors. About 121 adults aged 18 to 75 will take part.

Why investors are watching

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical is testing FZ-AD004, its first-in-human drug for advanced solid tumors, in a Phase 1 trial with 121 participants. For a small-cap company, this readout is a major test of whether the drug is safe and shows signs of working, which could shape the company's pipeline value.

If it works: If the drug proves safe and shows disease control in some participants, the company could advance to later-stage trials and strengthen its position in cancer treatment.

If it fails: Phase 1 trials often fail because the drug is unsafe or ineffective. A failure or delay could set back the company's pipeline and hurt its prospects, since this is an early and high-risk test.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 121 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced and metastatic solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, China

  • Shanghai Chest Hospital, Shanghai Jiaotong University, School of Medicine

    RECRUITING

    Shanghai, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, China

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