New bladder cancer cocktail aims to outdo chemo
NCT ID NCT07393542
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 453 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Immunotherapy combo aims to stall advanced bladder cancer
- New study tests Nerve-Saving support for bladder cancer patients
- Could less chemo mean better quality of life for bladder cancer patients?
- Bladder cancer treatment patterns under the microscope
- Real-World data shows avelumab helps control advanced bladder cancer after chemo
- New hope for bladder cancer: experimental drug joins standard combo