A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

Phase 3RecruitingNCT05302284

RemeGen Co., Ltd.452 enrolled

Overview

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.

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 (MMAE) conjugate, in Combination With JS001,a PD-1 monoclonal antibody, for the treatment of Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

452

Conditions

Urothelial Carcinoma HER2-expressing

Interventions

RC48-ADCDRUG

2.0 mg/kg IV every 2 weeks

ToripalimabDRUG

3.0 mg/kg IV every 2 weeks

GemcitabineDRUG

1000mg/m2 IV infusion on Days 1 and 8 of every 3 week cycle

Cisplatin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Beijing Cancer Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Progression-free survival (PFS), evaluated by independent review committee

Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by independent review committee according to the RECIST 1.1 standard.