drugset / Trial / NCT05575804
GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this trial is to study the safety, pharmacokinetics and preliminary efficacy of the HER2-targeted antibody-drug conjugate GQ1001 in combination with pyrotinib in patients with HER2-positive metastatic breast cancer patients who had failed previous anti-HER2 treatment.
Timeline
- Start
- 2022-10-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | GQ1001 | Other / unclassified | — | Intravenous |
| Subject | Pyrotinib | Small molecule | 320 mg | Oral |
| Subject | Pyrotinib | Small molecule | 400 mg | Oral |