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Antibody-drug conjugate

RC48-ADC for Advanced Breast Cancer with Liver Metastases

Phase 2 & 3
Waitlist Available
Research Sponsored by RemeGen Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death from any cause, assessed up to 48 months
Awards & highlights

Summary

This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.

Eligible Conditions
  • Advanced Breast Cancer with Liver Metastases
  • Breast Cancer
  • Breast Disease
  • Capecitabine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death from any cause, assessed up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death from any cause, assessed up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS) as Assessed by an IRC
Secondary study objectives
Clinical Benefit Rate （CBR）
Duration of Objective Response (DOR)
Objective Response Rate （ORR）
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RC48-ADCExperimental Treatment1 Intervention
Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
Group II: Lapatinib + CapecitabineActive Control2 Interventions
Participants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m\^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RC48-ADC
2019
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

RemeGen Co., Ltd.Lead Sponsor
80 Previous Clinical Trials
10,662 Total Patients Enrolled
~41 spots leftby Sep 2025
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