Combination treatment for advanced urothelial carcinoma
A Open-Label, Multicenter, Randomised, Controlled Phase 3 Study of RC48-ADC Plus Toripalimab Versus Chemotherapy Alone in Previously Untreated Unresectable Locally Advanced or Metastatic Urothelial Carcinoma With HER2-Expressing
This study is testing a new combination treatment for advanced bladder cancer to see if it works better than chemotherapy alone for patients who haven't received treatment before.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 452 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RemeGen Co., Ltd. Industry-sponsored |
| Drugs / interventions | Toripalimab, chemotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT05302284 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with HER2-expressing unresectable locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.
Not a fit: Patients with known hypersensitivity to the study drugs or those with prior systemic therapy for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective first-line option for patients with advanced urothelial carcinoma.
How similar studies have performed: Other studies have shown promising results with similar HER2-targeted therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.