Trials / Unknown
UnknownNCT04329429
A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer
An Open-label, Single-arm, Multi-center, Phase II Study of RC48-ADC in Subjects With HER2 Overexpressed Locally Advanced or Metastatic Biliary Tract Cancer (BTC) Who Have Failed First-line Chemotherapy
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- RemeGen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2 overexpressed biliary tract cancer who have failed first-line chemotherapy.
Detailed description
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2 overexpressed biliary tract cancer who have failed first-line chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RC48-ADC | The eligible patients will be treated with RC48-ADC, an antibody-drug conjugate, 2.5 mg/kg, once every two weeks until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first) |
Timeline
- Start date
- 2020-08-24
- Primary completion
- 2023-11-03
- Completion
- 2024-06-30
- First posted
- 2020-04-01
- Last updated
- 2023-12-20
Locations
16 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04329429. Inclusion in this directory is not an endorsement.