Actively Recruiting
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Led by RemeGen Co., Ltd. · Updated on 2023-12-18
452
Participants Needed
2
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expected survival of at least 12 weeks
- Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma from renal pelvis, ureters, bladder, or urethra
- No prior systemic therapy for locally advanced or metastatic urothelial carcinoma, except neoadjuvant or adjuvant chemotherapy with recurrence more than 6 months after completion
- At least one measurable lesion per RECIST version 1.1
- HER2-expressing status confirmed as IHC 1+, 2+ or 3+ by central laboratory
- ECOG performance status of 0 or 1
- Adequate cardiac, bone marrow, liver, kidney, and coagulation function
You will not qualify if you...
- Known allergy to RC48-ADC, Toripalimab, or their components
- Major surgery within 4 weeks before starting trial treatment
- Toxicity from previous treatment not recovered to Grade 0-1
- Prior treatment with antibody-drug conjugates or PD-1/PD-L1 inhibitors
- Active central nervous system metastases
- Active hepatitis B, hepatitis C, or HIV infection
- History of other cancers within 5 years except low-risk prostate cancer, treated cervical carcinoma in situ, non-melanoma skin cancer, or similarly curable cancers
- Serious uncontrolled diseases affecting study compliance or outcome interpretation, including active infections or uncontrolled diabetes
- Active autoimmune diseases requiring systemic therapy within past 2 years (replacement therapies allowed)
- Unable or unwilling to follow study requirements as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jianmin Fang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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