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

NCT05302284 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2023-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

RC48-ADC

2.0 mg/kg IV every 2 weeks

DRUG

Toripalimab

3.0 mg/kg IV every 2 weeks

DRUG

Gemcitabine

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

DRUG

Cisplatin

70mg/m2 IV infusion on Day 1 of every 3 week cycle

DRUG

Carboplatin

AUC=4.5, IV infusion on Day 1 of every 3 week cycle

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Na Su, PhD · RemeGen Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2026-12-31
Completion
2028-04-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05302284 on ClinicalTrials.gov