NCT05302284 A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
| NCT ID | NCT05302284 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | RemeGen Co., Ltd. |
| Condition | Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 452 participants |
| Start Date | 2022-06-14 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 452 participants in total. It began in 2022-06-14 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Na Su, PhD
STUDY DIRECTOR
RemeGen Co., Ltd.
Frequently Asked Questions
Who can join the NCT05302284 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05302284 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 452 participants.
Is NCT05302284 currently recruiting?
Yes, NCT05302284 is actively recruiting participants. Contact the research team at jianminfang@hotmail.com for enrollment information.
Where is the NCT05302284 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT05302284 clinical trial?
NCT05302284 is sponsored by RemeGen Co., Ltd.. The principal investigator is Na Su, PhD at RemeGen Co., Ltd.. The trial plans to enroll 452 participants.