RecruitingPhase 3NCT05302284

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

Sponsor

RemeGen Co., Ltd.

Enrollment

452 participants

Start Date

Jun 14, 2022

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma HER2-expressing

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria10

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.