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Urothelial CarcinomaPhase 3NCT07526792

SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

A Phase 3 study testing SYS6002 and Investigator's Choice of Chemotherapy in people with Urothelial Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy,safety PK characteristics, and immunogenicity of SYS6002 compared with chemotherapy in participants with locally advanced or metastatic urothelial carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Urothelial Carcinoma
What is being tested?
SYS6002 and Investigator's Choice of Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
No sites listed yet
Study dates
20 Jun 2026to 1 Dec 2029
Phase
Phase 3
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

  • 1.Participantss aged 18-75 years (inclusive);
  • 2. Pathologically confirmed patients with locally advanced or metastatic urothelial carcinoma
  • 3 Participants havefailed of platinum-based chemotherapy and PD-(L)1 inhibitors; for participants who received platinum-based chemotherapy and PD-(L)1 inhibitors in the adjuvant/neoadjuvant setting, disease recurrence or progression must have occurred within 12 months after completion of that therapy; radiographically confirmed disease progression during or after the most recent treatment regimen;
  • 4 Participants must have measurable disease according to RECIST (version 1.1);
  • 5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • 6 Life expectancy of ≥ 3 months;
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  • 7 Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to treatment;
  • 8 Sexually active fertile participants must agree to use methods of contraception during the study and at least 6 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;
  • 9 Willing to participate in the study, understand the study procedures, and sign a written informed consent form.

Who cannot join

  • 1. Active central nervous system metastases or leptomeningeal metastasis;
  • 2. Prior Nectin-4-targeted therapy;
  • 3. Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v5.0；
  • 4. Any serious and/or uncontrolled concurrent illness that may interfere with patient's participation in the study:
  • History of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval > 480 ms by Fridericia method (Fridericia formula: QTcF = QT/RR^0.33, RR = 60/heart rate);
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  • With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery;
  • New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) < 50% in the tests and examinations during the screening period;
  • Ischemic or Hemorrhagic Stroke;
  • Pulmonary Embolism Accident;
  • Other clinically significant diseases:
  • HbA1c > 8%;
  • Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness;
  • Grade ≥2 neuropathy prior to randomization;
  • Severe infection within 4 weeks prior to randomization; Active infection of Grade ≥2 (CTCAE v5.0) requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to randomization;
  • Active HBV or HCV infection;
  • History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation;
  • History of another malignancy within 3 years prior to randomization;
  • History of interstitial lung disease (ILD) / non-infectious pneumonia, or current ILD/non-infectious pneumonia, or imaging findings at screening that cannot rule out these condition, except for those who are determined to be risk-free after discussion between the investigator and the sponsor;
  • Pleural effusion, ascites or pericardial effusion with syptoms or requiring puncture or drainage within 2 weeks prior to randomization;
  • 5. Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy, or targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization; or major surgery within 4 weeks prior to randomization;
  • 6. Allergy to any component of SYS6002 or to humanized monoclonal antibodies;
  • 7. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

About this study

Official title: A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial of SYS6002 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure of Platinum-based Chemotherapy andPD-(L)1 Inhibitors

This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy,safety PK characteristics, and immunogenicity of SYS6002 compared with chemotherapy in participants with locally advanced or metastatic urothelial carcinoma.

This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will commence only after formal approval is obtained from the relevant Ethics Committee).

Being tested
SYS6002, Investigator's Choice of Chemotherapy
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • SYS6002Drug

    SYS6002 by intravenous (IV)

  • Investigator's Choice of ChemotherapyDrug

    Investigator's choice of chemotherapy means the chemotherapy chosen by investigators to treat urothelial carcinoma including docetaxel (75 mg/m^2 by IV on Day 1, every 21 days),paclitaxel (175 mg/m^2 by IV on Day 1, every 21 days)or pemetrexed (500 mg/m^2 by IV on Day 1, every 21 days) ).

Study groups in NCT07526792
Study groupRoleWhat they receive
SYS6002ExperimentalSYS6002 monotherapy
Receives: Drug: SYS6002
ChemotherapyActive comparatorInvestigator's choice of one of chemotherapy treatment (docetaxel, paclitaxel or pemetrexed)
Receives: Drug: Investigator's Choice of Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.

    Measured: Up to approximately 3 years

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.

    Measured: Up to 3 years

  2. Duration of Response (DOR)

    DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first

    Measured: Up to 3 years

  3. Disease Control Rate (DCR)

    The percentage of participants who experience a best response of CR, PR or stable disease (SD).

    Measured: Up to 3 years

  4. Progression Free Survival (PFS)

    PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.

    Measured: Up to 3 years

  5. Incidence of adverse events

    Measured: Up to 3 years

  6. Incidence of Anti-Drug Antibody (ADA)

    Measured: Up to 3 years

  7. Blood concentration of SYS6002

    Measured: Up to 3 years

Timeline

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

  1. First posted13 Apr 2026
  2. Study start20 Jun 2026 (estimated)
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible Participants in this trial will be randomized in a 1:1 ratio to one of two treatment arms
Masking
None (open label)
Enrolment
406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07526792
Sponsor's protocol ID
SYS6002-004
Status last verified
Apr 2026
First submitted
7 Apr 2026
Last updated
13 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYS6002 and Investigator's Choice of Chemotherapy in people with Urothelial Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

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 9 inclusion and 23 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Up to approximately 3 years). 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 NCT07526792.

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 13 Apr 2026.

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