Trials / Unknown
UnknownNCT05745740
A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation
An Open-label, Single-center, Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of RC48-ADC Combined With Pyrotinib in Local Advanced or Metastasis NSCLC With HER2 Mutation
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- Sponsor
- RemeGen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RC48-ADC | RC48-ADC 1.5/2.0 mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle |
| DRUG | Pyrotinib | Pyrotinib 400 mg by oral once a day. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2023-02-27
- Last updated
- 2023-11-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05745740. Inclusion in this directory is not an endorsement.