A Study of RC48-ADC in Subjects With Advanced Breast Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

December 23, 2016

Primary Completion Date

July 31, 2022

Study Completion Date

April 7, 2023

Conditions
Advanced Breast Cancer
Interventions
DRUG

RC48-ADC 1.5 mg/kg (HER2 Positive)

15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 1.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

DRUG

RC48-ADC 2.0 mg/kg (HER2 Positive)

15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.0mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

DRUG

RC48-ADC 2.5 mg/kg (HER2 Positive)

15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

DRUG

RC48-ADC 2.0 mg/kg (HER2 Low Expression)

45 advanced breast cancer participants with HER2 Low Expression will be treated with RC48-ADC at a dose of 2.0 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

Trial Locations (7)

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Unknown

The first bethune hospital of jilin unversity, Changchun

Liaoning cancer hospital & institute, Shenyang

Zhejiang cancer hospital, Hangzhou

Affiliated cancer hospital of Harbin medical university, Harbin

The fourth hospital of Hebei medical university, Hebei

Jiangsu Cancer Hospital, Nanjing

All Listed Sponsors
lead

RemeGen Co., Ltd.

INDUSTRY

NCT03052634 - A Study of RC48-ADC in Subjects With Advanced Breast Cancer | Biotech Hunter | Biotech Hunter