Status:
RECRUITING
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
Urothelial Carcinoma
HER2-expressing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Unresectab...
Detailed Description
This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study to evaluate the efficacy and safety of RC48-ADC,a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT05302284
Start Date
June 14 2022
End Date
April 30 2028
Last Update
December 18 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
2
Beijing Cancer Hospital
Beijing, China