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New bladder cancer cocktail aims to outdo chemo

NCT ID NCT07393542

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether a combination of two drugs, SHR-A2102 and adebrelimab, works better than standard chemotherapy for people with advanced bladder cancer that has not been treated before. About 462 participants will be randomly assigned to receive either the new combo or chemo. The main goal is to see if the new combo delays cancer growth or improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-A2102 and adebrelimab
What this could lead to
If successful, this could offer a new first-line treatment option for advanced bladder cancer that may work better than current chemotherapy.
What could go wrong
This is an early-phase 3 trial, so results are not yet known. The new combination may not prove superior to standard chemo and could have unexpected side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 453 people

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

Started

Feb 2026

Expected to finish

Oct 2030

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 80 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. Be able to sign the informed consent form in writing. 2. Female or male, 18 to 80 years of age (both inclusive). 3. ECOG performance status of 0 or 1. 4. Expected survival of≥ 3 months. 5. Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic disease. 6. No prior systemic therapy for locally advanced or metastatic disease. 7. Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression. 8. According to RECIST v1.1, there must be at least one measurable lesion; 9. Tolerant to cisplatin or carboplatin. 10. Adequate organ functions. 11. Agree to use medically approved contraceptive measures. Exclusion Criteria: 1. Planned to receive any other anti-tumor therapy during the study. 2. Received other investigational products or treatments not yet marketed within 4 weeks. 3. Have received systemic anti-tumor treatment within 4 weeks;have received prior anti-tumor Chinese patent medicine treatment within 2 weeks; palliative radiotherapy or local therapy within 2 weeks. 4. Previously received therapy with an antibody-drug conjugate that meets any one of the following characteristics: targeting Nectin-4; containing irinotecan or its derivatives and acting as a topoisomerase I inhibitor. 5. Prior treatment with immune checkpoint inhibitors. 6. Major surgical procedure other than diagnostic or biopsy within 4 weeks, requiring elective surgery during the trial. 7. Active autoimmune disease requiring systemic treatment within 2 years. 8. Have experienced adverse events caused by previous anti-tumor treatments that have not recovered to grade ≤1 as per NCI-CTCAE v5.0. 9. Uncontrolled central nervous system metastases or carcinomatous meningitis. 10. Subjects with clinical symptoms or serous cavity effusion requiring puncture drainage. 11. Other malignancies within 5 years. 12. History of clinically significant pulmonary disease or any such disease suggested by chest imaging at screening. 13. Serious infections requiring intravenous antibiotics, antivirals, or antifungals for control. 14. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 15. History of immunodeficiency, or history of organ transplant. 16. Have experienced arteriovenous thrombosis or cardiovascular and cerebrovascular accidents within 6 months. 17. Subjects with clinically significant hemorrhage within 3 months. 18. Glycosylated hemoglobin (HbA1c) ≥ 8%. 19. Have serious cardiovascular and cerebrovascular diseases. 20. Allergic reaction to any component of the study treatment. 21. Subjects with active pulmonary tuberculosis. 22. History of severe dry eye, active keratitis, or corneal ulcer, or other conditions. 23. Female Subjects who are pregnant or planning to become pregnant during the study. 24. Other conditions unsuitable into the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

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