Combination treatment for advanced urothelial carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, open-label, multicenter, randomized, controlled study aims to evaluate the efficacy and safety of RC48-ADC, a HER2-targeted antibody-drug conjugate, combined with Toripalimab, a PD-1 monoclonal antibody, compared to chemotherapy alone in patients with previously untreated HER2-expressing unresectable locally advanced or metastatic urothelial carcinoma. The study will assess the treatment's impact on tumor response and patient outcomes. Participants must have measurable disease and meet specific health criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Expected survival ≥12 weeks.
* Locally advanced unresectable or metastatic UC with histopathological confirmation, including UC originating from the renal pelvis, ureters, bladder, or urethra.
* Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions:

Participants that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; Participants that received adjuvant chemotherapy following cystectomy with recurrence \>6 months from completion of therapy are permitted.

* At least one measurable lesion based on RECIST version 1.1
* HER2-expressing status determined by the central laboratory to be IHC 1+, 2+ or 3+.
* ECOG performance status score: 0 or 1.
* Adequate cardiac, bone marrow, hepatic, renal, and coagulation functions.

Exclusion Criteria:

* Known hypersensitivity to RC48-ADC or Toripalimab or any of its components.
* History of major surgery within 4 weeks of planned start of trial treatment.
* Toxicity from a previous treatment has not returned to Grade 0-1.
* Prior ADCs or PD-1/PD-L1 inhibitor therapy.
* Active central nervous system (CNS) metastases.
* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
* History of other malignancy within the previous 5 years, except for low-risk localized prostate cancer, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
* Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.
* Active autoimmune diseases that require systemic therapy over the past 2 years. Replacement therapies (such as thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed.
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jianmin Fang, PhD
• Email: jianminfang@hotmail.com
• Phone: +86-010-58075561

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.