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

NCT07526792 | Not Yet Recruiting Phase 3

• 1 other identifier: SYS6002-004
• Study Type: interventional
• Target: 406
• Locations: 0 countries
• Sites: N/A

Brief 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. 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).

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (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.

  Up to approximately 3 years

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Up to 3 years

• Duration of Response (DOR)

  Up to 3 years

• Disease Control Rate (DCR)

  Up to 3 years

• Progression Free Survival (PFS)

  Up to 3 years

• Incidence of adverse events

  Up to 3 years

Study Arms (2)

SYS6002

EXPERIMENTAL

SYS6002 monotherapy

Drug: SYS6002

Chemotherapy

ACTIVE COMPARATOR

Investigator's choice of one of chemotherapy treatment (docetaxel, paclitaxel or pemetrexed)

Drug: Investigator's Choice of Chemotherapy

Interventions

SYS6002 DRUG

SYS6002 by intravenous (IV)

SYS6002

Investigator's Choice of Chemotherapy DRUG

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) ).

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participantss aged 18-75 years (inclusive);
• \. Pathologically confirmed patients with locally advanced or metastatic urothelial carcinoma
• 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;
• Participants must have measurable disease according to RECIST (version 1.1);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Life expectancy of ≥ 3 months;
• Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to treatment;
• 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;
• Willing to participate in the study, understand the study procedures, and sign a written informed consent form.

You may not qualify if:

• \. Active central nervous system metastases or leptomeningeal metastasis;
• \. Prior Nectin-4-targeted therapy;
• \. Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v5.0；
• \. 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);
• 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;

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible Participants in this trial will be randomized in a 1:1 ratio to one of two treatment arms

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04