Trials / Completed
CompletedNCT03052634
A Study of RC48-ADC in Subjects With Advanced Breast Cancer
A Phase Ib Study to Evaluate the Efficacy, Safety and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Breast Cancer With HER2 Positive or HER2 Low Expression
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- RemeGen Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection in subjects with advanced breast cancer with HER2 positive or HER2 low expression
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-12-23
- Primary completion
- 2022-07-31
- Completion
- 2023-04-07
- First posted
- 2017-02-14
- Last updated
- 2023-12-18
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03052634. Inclusion in this directory is not an endorsement.