NCT05302284RecruitingPhase 3
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of 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
Source: ClinicalTrials.gov · Last updated 18 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 452 (estimated)
- First submitted
- 21 Mar 2022
- Start date
- 14 Jun 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- RemeGen Co., Ltd.
- Diseases
- Bladder cancer
- NCT number
- NCT05302284
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 452
- From 14 Jun 2022 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Active central nervous system (CNS) metastases.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.