Trials / Completed
CompletedNCT04073602
A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer
An Open-label, Single-arm, Single-center, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in Subjects With HER2-negative Metastatic or Unresectable Urothelial Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- RemeGen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 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-negative urothelial cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RC48-ADC | The eligible patients will be treated with RC48-ADC, an antibody-drug conjugate, 2.0 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
- 2019-08-19
- Primary completion
- 2022-09-30
- Completion
- 2023-01-31
- First posted
- 2019-08-29
- Last updated
- 2023-12-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04073602. Inclusion in this directory is not an endorsement.