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Advanced Urothelial CarcinomaPhase 2NCT07374549

SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma

A Phase 2 study testing SYS6002 and enfortumab vedotin in people with Advanced 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, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma. This study has not yet been submitted for ethical review. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Urothelial Carcinoma
What is being tested?
SYS6002 and enfortumab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
20 Jun 2026to 1 Dec 2028
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients aged 18-80 years (inclusive);
  • 2. Pathologically confirmed patients with advanced urothelial carcinoma who have received a platinum-based chemotherapy with anti-PD-(L)1 agent. For those who received these therapies in the adjuvant or neoadjuvant setting, disease progression must have occurred during treatment or within 12 months of treatment completion;
  • 3 An archival tumor tissue sample or a fresh tissue sample should be provided;
  • 4 Subjects 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 Major organ function must meet the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;
  • 8Sexually active fertile subjects must agree to use methods of contraception during the study and at least 7 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.Adverse events from prior anti-tumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk)；
  • 3.Any serious and/or uncontrolled concurrent illness that may interfere with patient's participation in the study:
  • Participants with a 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); 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; cerebrovascular accidents; pulmonary embolisms;
  • Other clinically significant diseases:
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  • 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 requiring systemic antibiotics, antiviral, or antifungal therapy 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 conditions, 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 symptoms or requiring puncture or drainage within 2 weeks prior to randomization;
  • 4.Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy 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;with major surgery within 4 weeks prior to randomization;
  • 5.Allergy to any component of SYS6002, or humanized monoclonal antibodies; investigator-determined ineligibility for enfortumab vedotin therapy.
  • 6. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

About this study

Official title: A Randomized, Open-Label, Controlled, Multicenter Phase 2 Trial of SYS6002 Versus PADCEV in Patients With Advanced Urothelial Carcinoma

This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma.

This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.

Being tested
SYS6002, enfortumab vedotin

What participants receive

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

  • SYS6002Drug

    SYS6002 by intravenous (IV)

  • enfortumab vedotinDrug

    1.25 mg/kg by IV on Day 1、8、15, every 28 days.

Study groups in NCT07374549
Study groupRoleWhat they receive
SYS6002Active comparatorNot described
Receives: Drug: SYS6002
enfortumab vedotinActive comparatorenfortumab vedotin monotherapy
Receives: Drug: enfortumab vedotin

What is being measured

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

  1. Occurrence and frequency of Adverse Event (AE)

    Measured: Up to approximately 2 years

Secondary outcomes (8)

  1. Incidence of treatment-related peripheral neuropathy and≥1-grade worsening in treatment-related peripheral neuropathy from baseline

    Measured: Up to 2 years

  2. Incidence of treatment-related hyperglycemia

    Measured: Up to 2 years

  3. Incidence of treatment-related cutaneous adverse reactions

    Measured: Up to 2 years

  4. 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 2 years

  5. 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 2 years

  6. Disease Control Rate (DCR)

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

    Measured: :Up to 2 years

  7. 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 2 years

  8. Overall Survival

    Measured: Up to 2 years

Timeline

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

  1. First posted29 Jan 2026
  2. Study start20 Jun 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Dec 2028 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants in this trial will be randomly assigned to one of two groups.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07374549
Sponsor's protocol ID
SYS6002-00X
Status last verified
Jan 2026
First submitted
21 Jan 2026
Last updated
29 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SYS6002 and enfortumab vedotin in people with Advanced 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 10 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 29 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Occurrence and frequency of Adverse Event (AE) (time frame: Up to approximately 2 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 NCT07374549.

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 29 Jan 2026.

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