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Promising drug combo aims to wipe out bladder cancer before surgery

NCT ID NCT07314723

Disease control Sponsor: Mabwell (Shanghai) Bioscience 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether combining two drugs (9MW2821 and toripalimab) before and after surgery can improve outcomes for people with urothelial cancer (a type of bladder cancer). About 90 adults with non-spread cancer will receive the treatment and be monitored for tumor shrinkage and safety. The goal is to see if this approach can eliminate visible cancer and delay or prevent recurrence.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

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

Started

Aug 2025

Expected to finish

Dec 2028

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 years and older

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: * Sign the informed consent form approved by IEC. * Male or female subjects aged ≥18 years old. * ECOG status: 0 or 1. * Histologically confirmed urothelial cancer. * Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0. * Adequate tumor tissues submitted for test. * Life expectancy for more than 12 weeks. * Adequate organ functions. * Proper contraception methods. * Willingness to follow the study procedures. Exclusion Criteria: * Prior systemic anti-tumor therapy for urothelial cancer. * Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs). * History of another malignancy within 3 years. * History of autoimmune disease requiring systemic treatment within 2 years. * History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 1 year. * Major surgery treated within 28 days; Cystoscopy/ureteroscopy biopsy or intravesical instillation therapy within 7 days. * Peripheral neuropathy Grade ≥ 2. * Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc. * Active HBV/HCV/HIV infection, etc. * Any other serious chronic or uncontrolled disease. * Any live vaccines got within 28 days. * Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past. * Any potent CYP3A4 inducers/inhibitors taken within 14 days. * Known allergic sensitivity to any of the ingredients of the study drug. * History of drug abuse or mental illness. * Other conditions unsuitable into the study.

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Urothelial carcinoma

How to take part

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

  1. The places running it

    1 site. 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

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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