Tests RC48-ADC with toripalimab against chemotherapy for bladder cancer
Tests RC48-ADC with toripalimab in adults with HER2-expressing urothelial carcinoma.
Plain-language title generated from the registry record
Registry title: A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Key facts
- Where
- Beijing, ChinaSee the 2 sites
- Phase
- Phase 3
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RemeGen Co., Ltd.
- Trial code
- NCT05302284
- Record updated
- 18 December 2023
- Original description
This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.Read full original descriptionShow less
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 is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.
Inclusion: 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: Toxicity from a previous treatment has not returned to Grade 0-1; Prior ADCs or PD-1/PD-L1 inhibitor therapy; 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; 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; 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; 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; Active central nervous system (CNS) metastases; Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.